Our services:

Regulatory strategies for submissions of medicinal products to the UK and EU Competent Authorities (NP, MRP, DCP, CP)
Evaluation, preparation, submission and management of Marketing Authorisation Applications, variations, renewals, notifications and other applications to the UK and EU Competent Authorities
Interactions and liaising with national competent authorities;
Due diligence of registration dossiers for medicinal products
Dossier compiling
CMC writing
Expert's reports, QOS's, non-clinical and clinical summaries, ERAs
SOP authoring, reviewing and updating
Maintenance of the Quality Management System in line with ISO 9001 requirements for Regulatory Affairs departments and teams

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