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Eurofins CDMO

GALENIX INNOVATIONS

Skyepharma

Unither Pharmaceuticals

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FRANCE

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

Regulatory Services

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- 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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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

Regulatory Expertise

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- Service Details

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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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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- 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.

- Directory Listing

Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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

Regulatory Affairs

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- Service Details

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

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

European & US DMF

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- Service Details

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

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

IMPD, pre-IND meeting, IND, etc…

Contact the Supplier

- Service Details

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

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

Marketing Authorization Application C.T.D., A...

Contact the Supplier

- Service Details

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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