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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

We provide regulatory services with a track record of supporting regulatory approvals for oral dosage forms in US, Europe, etc. We ensure registration & post-approval strategies, regulatory agency inquiries & inspections and lifecycle management support

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

Virtual BoothStreamline Drug Development - bring your Drug to Clinic Faster.

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.

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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

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 / Pharmacovigilance

Sub Category: France

Virtual BoothStreamline Drug Development - bring your Drug to Clinic Faster.

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.

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

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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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