Regulatory Affairs at Eignapharma

At Eignapharma we have strong regulatory knowledge on the both national and international markets, providing support to our clients since 2010. Our experienced regulatory affairs team will listen to your needs and provide a tailored service, supporting our clients in many different areas, such as medicines for human use, food supplements and foods for specific groups, medical devices and cosmetics.

While preparing for dossier submission

Readability User Test (RUT) & Bridging Reports.

Dossier Due Diligences.

e-CTD Publication (Sequence 000).

Regulatory strategy design & regulatory fees cost calculation.

Product Information (PI) & labelling translation.

From submission to MA grant

National Procedure (NP).

Decentralised Procedure (DCP).

Mutual Recognition Procedure (MRP).

Centralised Procedure (CP).

Multiple applicants available.

Creation of regulatory mock-ups.

e-CTD Publication (Sequence 001 onwards).

European Directorate for the Quality of Medicines (EDQM)

Certification of Suitability.

  • New Applications.

Upon MA grant

Submission of variations*

Submission of renewals*

Variations strategy

Portfolio Acquisition Due Diligences

MA transfer

*Including support for regulatory submission fees payment.