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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

Neuraxpharm

Orofino Pharmaceuticals Group

PHA Farmed d.o.o

PLS Pharma

RegPak BioPharma

Rochem International Inc

Skyepharma

Transo-Pharm Handels-GmbH

UQUIFA

Unither Pharmaceuticals

Vitalchemie Corp.

Wavelength Pharmaceuticals

Zaphyr Pharmaceuticals

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ALGERIA

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Virtual BoothExpert and Agile CDMO Partner for tailor-made solutions.

Regulatory Services

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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 / Pharmacovigilance

Sub Category: France

Virtual BoothGeneric API development & supply// Non-infringement patent strategies development// Regulatory support.

Compliance & Regulatory Support

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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 / Pharmacovigilance

Sub Category: United States

Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and Oligonucleotides.

Regulatory Support

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- 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 / Pharmacovigilance

Sub Category: Switzerland

Virtual BoothYour Partner For Brazil

Providing Regulatory Solutions in Brazil

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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 / Pharmacovigilance

Sub Category: Brazil

Virtual BoothWe connect - People, Mentalities and Markets in APIs

Scientific & Regulatory Support

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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 / Pharmacovigilance

Sub Category: Germany

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Regulatory Support for APIs & Medical Devices...

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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 / Pharmacovigilance

Sub Category: Singapore

Virtual BoothGlobal leader in developing, sourcing and supplying pharmaceutical & animal health ingredients of Chinese origin

Expertise to File & Maintain DMFs/COS in USA

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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 / Pharmacovigilance

Sub Category: United States

Virtual BoothWorld-Class Developer & Manufacturer of Differentiated APIs// in 50 countries// 198 DMFs Worldwide.

Complete Regulatory Support

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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 / Pharmacovigilance

Sub Category: Israel

Virtual BoothYour Drug Development partner of drug substance/API and Drug Product Operations for biologics and small molecules.

IND / IMPD Services

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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 / Pharmacovigilance

Sub Category: France

Virtual BoothDevelopment, Manufacturing & Marketing of Pharmaceuticals for Central Nervous System Pathologies.

Regulatory Dossiers

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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 / Pharmacovigilance

Sub Category: Spain

Virtual BoothNeuraxpharm's APIs manufacturing plant

Regulatory Services

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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 / Pharmacovigilance

Sub Category: Spain

Virtual BoothContract manufacturing services: Biopharma:(Penicillins, Cephalosporins and Carbapenems),Injectalia (Hormones and Biological products)

Regulatory Support & Tech Support

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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 / Pharmacovigilance

Sub Category: Switzerland

Virtual BoothUnither Pharmaceuticals, a world-leading pharmaceutical contract development manufacturing organization (CDMO)

Regulatory Expertise

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Unither's regulatory expertise compile the registration dossiers (Product Quality Part) related to operations performed by their technical experts in Formulation, Process development, Analytical development & validation, and Stability studies.

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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Providing In/Out Licensing Services

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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 / Pharmacovigilance

Sub Category: India

Virtual BoothChemistry for a better life

Regulatory Support & Validation

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- 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 / Pharmacovigilance

Sub Category: Spain

Virtual BoothYour Contract Manufacturing Partner for all Dosage Forms & Global Market

Dossiers Submission & Approval

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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 / Pharmacovigilance

Sub Category: India

Virtual BoothProviding complete Pharmaceutical Outsourcing Solutions to Pharmaceutical Industry

Regulatory Support - India

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- 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

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: India

Virtual BoothCompetence center of HELM Group for the commercialization of APIs. APIs distributed by Helm: Ascorbic Acid EP (CEP), Heparin (CEP)

Regulatory Support

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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 / Pharmacovigilance

Sub Category: Portugal

Virtual Booth Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

Dossier Writing & Safety Assessment in Czech ...

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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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Czech republic

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CRO Operating in MENA Region

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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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Lebanon

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Provides Dossiers in Full CTD & eCTD Format i...

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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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Algeria

Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and Oligonucleotides.

Regulatory Documentation

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- 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)

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

Virtual BoothGlobal leader in developing, sourcing and supplying pharmaceutical & animal health ingredients of Chinese origin

Expertise to File & Maintain DMFs/COS - China

Contact the Supplier

- 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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: China

Virtual BoothYour Drug Development partner of drug substance/API and Drug Product Operations for biologics and small molecules.

NDA / CTD Services

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- Service Details

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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

Virtual BoothContract manufacturing services: Biopharma:(Penicillins, Cephalosporins and Carbapenems),Injectalia (Hormones and Biological products)

Regulatory Support

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- 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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Italy

Virtual BoothProviding complete Pharmaceutical Outsourcing Solutions to Pharmaceutical Industry

Regulatory Support - US

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- 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

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

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Regulatory Consulting Services in Portugal

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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

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Portugal

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Services for Regulatory Approvals/Product Reg...

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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 / Pharmacovigilance

Sub Category: India

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Regulatory Teams Working in Cooperation With ...

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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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: China

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Services to Establish / Expand Client Busines...

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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 / Pharmacovigilance

Sub Category: Tunisia

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Services to Establish / Expand Client Busines...

Contact the Supplier

- 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 / Pharmacovigilance

Sub Category: Lebanon

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Services to Establish / Expand Client Busines...

Contact the Supplier

- 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 / Pharmacovigilance

Sub Category: Iran

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Services to Establish / Expand Client Busines...

Contact the Supplier

- 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 / Pharmacovigilance

Sub Category: Iraq

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Services to Establish / Expand Client Busines...

Contact the Supplier

- 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 / Pharmacovigilance

Sub Category: Saudi arabia

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Services to Establish / Expand Client Busines...

Contact the Supplier

- 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 / Pharmacovigilance

Sub Category: Egypt

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Services to Establish / Expand Client Busines...

Contact the Supplier

- 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 / Pharmacovigilance

Sub Category: Libya Arab Jamahiriya

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Services to Establish / Expand Client Busines...

Contact the Supplier

- 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 / Pharmacovigilance

Sub Category: Algeria