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Aastrid International Pvt. Ltd
AgRay s.r.o
Arlanda Import and Export Ltda
AvacaPharma
Bachem AG
Basic Pharma
Bioplus Care S.A
Biotechnica Pharma Global
CRMO Pharmmatecch
ChemWerth Inc
Eurofins CDMO
GALENIX INNOVATIONS
HELM Portugal
Hangzhou Pharmacare Lab. Co., Ltd
Inke S.A
KBP Biomak
KEMIMAC S PTE LTD
Lamda Laboratories
M2M Pharmaceuticals Ltd
Madras Pharmaceuticals
Navatio Pharma
Navitas Inc
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Orofino Pharmaceuticals Group
PHA Farmed d.o.o
PLS Pharma
RegPak BioPharma
Rochem International Inc
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Unither Pharmaceuticals
Vitalchemie Corp.
Wavelength Pharmaceuticals
Zaphyr Pharmaceuticals
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Expert and Agile CDMO Partner for tailor-made solutions.
- Service Details
Skyepharma provides services with a track record of supporting regulatory approvals for oral dosage forms in US, Europe, etc. They ensure registration & post-approval strategies, regulatory agency inquiries & inspections with lifecycle management support.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: France
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Our Regulatory team provides compliance & regulatory support by managing documentation creation, review and submission while our Compliance group manages our Factory Compliance Programs, CMO management and facility inspections.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: United States
- Service Details
Bachem also has a strong regulatory background and we are well prepared to fully support you with the required regulatory documentation such as drug master files (DMFs)
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Switzerland
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Formulation and Finished Products Business Unit offers a variety of products from various therapeutic areas for both Pharmaceutical as well Veterinary with an extensive experience in the negotiation, documentation, inspections and other requirements.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Brazil
We connect - People, Mentalities and Markets in APIs
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We offer scientific and regulatory services for the pharmaceutical industry and our suppliers (APIs and finished drugs, human and veterinary), primarily in the areas GMP, audits and inspections as well as regulatory affairs (eCTD).
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Germany
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Established in Nov 1980, Kemimac (S) Ptd Ltd started as a distributor for active pharmaceutical ingredients, pharmaceutical excipients and healthcare related finished products. Kemimac has evolved to become a supplies partner to many manufacturers, research facilities and health institutions
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Singapore
- Service Details
Regulatory submissions filed by Rochem are prepared by our U.S. and Qingdao, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: United States
World-Class Developer & Manufacturer of Differentiated APIs// in 50 countries// 198 DMFs Worldwide.
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Wavelength offers complete regulatory support to its customers throughout the product life cycle, starting from early development, through filing and commercial sales, to assure market leadership and sustainability.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Israel
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Eurofins CDMO regulatory experts will draft, review and manage the necessary documents to enable the building of Common Technical Document (CTD) for product registration and life-cycle submissions.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: France
Development, Manufacturing & Marketing of Pharmaceuticals for Central Nervous System Pathologies.
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Lesvi offers the complete range of Neuraxpharm’s FDF products (quality generics, pharmaceuticals and nutraceuticals) including access to our regulatory dossiers.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Spain
Neuraxpharm's APIs manufacturing plant
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Given the strong experience of Neuraxpharm's APIs manufacturing plant with the most demanding clients, Inke is able to provide full support to its clients.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Spain
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Orofino Pharmaceuticals Group can provide full regulatory and technical support for the transfer and validation of products in all of its plants. The technical expertise is available for the development & improvement of formulations and processes.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Switzerland
- Service Details
Our regulatory expertise compile the registration dossiers (Product Quality Part) related to operations performed by our technical experts in Formulation, Process development and validation, Analytical development and validation, ICH stability studies.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: France
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Over the years, from representing local businesses in the Pharmaceutical Industry, we have grown to represent manufacturers and distributors globally; and in the process, developed a network so comprehensive that it defines who we are and how we work as well.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
- Service Details
Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Spain
Your Contract Manufacturing Partner for all Dosage Forms & Global Market
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Madras Pharma has a distinguished regulatory department experienced in submitting more than 100 dossiers in all different formats (as required by the respective country) and getting approvals from both regulated and semi regulated countries.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
Providing complete Pharmaceutical Outsourcing Solutions to Pharmaceutical Industry
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CRMO can assist your company with FDA pre and post approval inspections, regulatory interpretation & submissions such as DMFs to the US FDA & EU Community, Dossiers for Certificate of Suitability of monographs of the European Pharmacopoeia, etc
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
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Best in class for dossier maintenance. Proven access into relevant EU agencies. Specific expertise on DMFs your partner for CEP approvals. Expertise for emerging markets: proven track record in MENA and LATAM.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Portugal
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- Service Details
AgRay offers Safety assessment, Post Authorisation Safety Studies, Dossier GAP analysis, Dossier compilation, localization, updating and translation, eCTD data dossier conversion, Full dossier writing from Modules II to V and MAA management.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Czech republic
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- Service Details
Over the past 20 years, Biotechnica Pharma Global (BPG) has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies all over the world.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Algeria
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A Belgo-Lebanese health consulting company offering services to the medical and pharmaceutical industries. A CRO offering clinical expertise to the pharmaceutical industry within the MENA region covering a population of around 300 million people.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Lebanon
- Service Details
Bachem also has a strong regulatory background and we are well prepared to fully support you with the required regulatory documentation such as drug master files (DMFs)
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: United States
- Service Details
Regulatory submissions filed by Rochem are prepared by our U.S. and Qingdao, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: China
- Service Details
Eurofins CDMO offers the skills & capability to prepare & review documents for clinical trial application (IND/IMPD). This includes manufacture & support for Phase I, II & III studies, IND/IMPD quality sections related to drug substance & drug product.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: France
- Service Details
Orofino Pharmaceuticals Group can provide full regulatory and technical support for the transfer and validation of products in all of its plants. The technical expertise is available for the development & improvement of formulations and processes.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Italy
Providing complete Pharmaceutical Outsourcing Solutions to Pharmaceutical Industry
- Service Details
CRMO can assist your company with FDA pre and post approval inspections, regulatory interpretation & submissions such as DMFs to the US FDA & EU Community, Dossiers for Certificate of Suitability of monographs of the European Pharmacopoeia, etc
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: United States
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- Service Details
PLS main business line is the import, representation and distribution of generic medicinal products hospital market. Additional business lines are ambulatory distribution and pharmaceutical services. It is licenced and regulated by the Portuguese Health A
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Portugal
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- Service Details
Aastrid offers a range of services for acquiring regulatory approvals/ product registrations. For APIs and excipients, we provide comprehensive services for preparing European Drug Master Files, as well as preparing, submitting, and following up with EDQM Certification of Suitability applications
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
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- Service Details
Pharmacare is one of the subsidiary companies of CONBA group, which is one of the leading pharmaceutical companies as well as a listed company in China, with more than 3000 sales representatives.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: China
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Tunisia
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Lebanon
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Iran
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Iraq
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Saudi arabia
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Egypt
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Libya Arab Jamahiriya
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Algeria
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- Service Details
Zaphyr is a Swiss based, multinational pharmaceutical company that in-licenses and commercializes specialized therapies in the Middle East and North Africa. They are committed to improve people's lives through innovative solutions.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Morocco
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Mexico
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Guatemala
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Belice
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Jamaica
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Bahamas
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Barbados
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Trinidad & Tobago
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Ecuador
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Panama
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Costa rica
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Nicaragua
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Honduras
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- Service Details
Regulatory affairs department is responsible for carrying out all the processes related to brand registration and sanitary certification, in addition to whichever other applicable requirements needed to be fulfilled to freely sell our products in differen
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: El salvador
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- Service Details
Market Access services for the customers who enters and develops their presence in Slovenia: pre-launch, launch and life-cycle support.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Slovenia
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- Service Details
The regulatory affairs department of Lamda offers a wide range of services including continuous monitoring of the product, evaluation of regulatory information & documentation for the registration of dossier, e-CTD submissions, Risk assessment reports.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Greece
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- Service Details
Navatio Pharma is a specialized Pharmacovigilance services provider that assists and enables small, medium and large Pharma and Biotech organizations to satisfy worldwide regulatory requirements.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
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- Service Details
It takes a thorough consideration to reach the long-term value in today’s sensitive marketing environment. We offer a full range of services to identify the key attributes that help our customers to efficiently launch the new product in Slovenia.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Slovenia
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- Service Details
RegPak provides RMP, PSUR, PSMF, Pharmacovigilance planning, QPPV services
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Netherlands
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- Service Details
In ICSR case processing, we perform triage, data entry, medical DRA (Drug Regulatory Affairs) coding, narrative writing, medical review, quality control, medical review and submission.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
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- Service Details
Compilation of dossiers and applications to obtain the Maximum Allowed Prices of medicinal products (MAP), Extraordinary permitted higher prices (EHAP) and to obtain the reimbursement by the national insurance funds.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Slovenia
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- Service Details
RegPak provides assistance with regulatory and GMP audits/Inspections
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Netherlands
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- Service Details
Navatio Pharma is a specialized Pharmacovigilance services provider that assists in aggregation of safety reports such as Periodic safety updated reports, Periodic benefit risk evaluation report, Periodic Adverse Drug Experience Report & annual reports.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
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- Service Details
Navatio Pharma provides strategic advice and analysis, develops US for risk evaluation and mitigation strategies (REMS). We also update REMS reports and make Risk management plans (RMPs) for Europe.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
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- Service Details
RegPak helps developing and executing pricing and reimbursement strategies for new products. Refining strategies for in-line products
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Netherlands
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- Service Details
RegPak helps developing and executing pricing and reimbursement strategies for new products. Refining strategies for in-line products
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Netherlands
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- Service Details
Navitas Life Sciences has the capabilities to support the regulatory end-to-end lifecycle management across the entire value chain of drug and device regulatory environment.
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Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: India
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- Service Details
RegPak assesses the liability risks of pharmaceutical regulation, registration, products and services represents a unique challenge.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Netherlands
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- Service Details
Regpak's regulatory consulting staff can provide you with support during both preclinical and clinical development, manufacturing, product licensing, and regulatory approvals.
- Directory Listing
Pharma Service: Sales, Marketing, Registration
Category: Regulatory Affairs / PharmacovigilanceSub Category: Netherlands
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- Service Details
Navitas Life Sciences has the capabilities to support the regulatory end-to-end lifecycle management across the entire value chain of drug and device regulatory environment.<
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