Regulatory Affairs

Due to rapid changes in regulatory affairs and ever-increasing demands, PRSG offers the following services for you.

Regulatory Support and Strategy

Regulatory advice during early stages of product development
Tailored project management for fast approval and trouble shooting
Consultation of authorities for scientific advice related to Quality, Non-Clinic and Clinic
Electronic platforms support (CESP, PLM, IRIS, SPOR, UPD, etc.)

Support for IMAA in national, mutual recognition, decentralised, and centralised procedures (NP, MRP, DCP, CP)
Definition of the appropriate application procedure and product status
Submission and procedural management throughout the authorisation process
Support in readability testing
Evaluation of regulatory and CMC documentation
Preparation of expert statements and overviews
Support in preparation and preparation of Modules 2–5
Development of pharmacological, toxicological, and clinical expert reports, as well as environmental risk assessments
eCTD (human) and vNeeS (veterinary) dossier compilation
Timely handling of deficiency letters from authorities
Compilation and translation of SmPCs and PILs (EN/DE and DE/EN) - national phase
Artwork review and quality check

Human and veterinary medicinal products
Radiopharmaceuticals
Biological products
Literature research
Dossier management and revisions
Classification, preparation and submission of variations
Processing of Follow-up-activities
Update of Product Information (SmPC, PIL and Labelling)
Preparation of pharmacological and toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.

Translation of SmPCs, PIL and Labelling from English to German and from German to English
Translation of dossier parts from German language to English
Proof reading of Product Information (Artwork review)
Artwork check