Skyepharma

Expert and Agile CDMO Partner for tailor-made solutions.

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France

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REGULATORY SERVICES

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Skyepharma has a track record of supporting regulatory approvals for oral dosage forms in the US, Europe, etc. It ensures registration & post-approval strategies, regulatory agency inquiries & inspections with life cycle management support.

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

AAPS PharmSci 2022

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Unither Pharmaceuticals

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France

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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

CPhI Worldwide 2022

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Eurofins CDMO

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France

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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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Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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Eurofins CDMO

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France

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NDA / CTD SERVICES

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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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Sub Category: France

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GALENIX INNOVATIONS

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France

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REGULATORY AFFAIRS

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Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

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Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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GALENIX INNOVATIONS

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France

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EUROPEAN & US DMF

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Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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GALENIX INNOVATIONS

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France

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IMPD, PRE-IND MEETING, IND, ETC…

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Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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GALENIX INNOVATIONS

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France

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MARKETING AUTHORIZATION APPLICATION C.T.D., ANDA, NDA

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Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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