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Providing Regulatory Solutions in Brazil

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> Brazil

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.

Regulatory Support for APIs & Medical Devices?

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> Singapore

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

Expertise to File & Maintain DMFs/COS in USA

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> United states

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.

IND / IMPD Services

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> France

Eurofins Contract Development & Manufacturing Organization offers the skills and capability to prepare and review documents for clinical trial application (IND/IMPD).

Regulatory Dossiers

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> Spain

Lesvi offers the complete range of Neuraxpharm’s FDF products (quality generics, pharmaceuticals and nutraceuticals) including access to our regulatory dossiers.

Regulatory Services

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> Spain

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.

Providing In/Out Licensing Services

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> India

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.

Regulatory Support and File Submission and Maintenance

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> Spain

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

Dossier Writing & Safety Assessment in Czech Republic

Sales, Marketing, Registration >> Regulatory Affairs / Pharmacovigilance >> Czech republic

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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