Regulatory Affairs at Eignapharma
At Eignapharma we have a sound 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, provoding support to 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*
Portfolio Acquisition Due Diligences
*Including support for regulatory submission fees payment.