First-rate Regulatory Affairs services for the Pharmaceutical Industry
EC drug registration
- National, Mutual Recognition & Decentralised Procedures
- Type I & II Variations, 5-year Renewals, Line Extensions …
- Dossier Preparation (e.g. New Indications, Rx / OTC switch)
- Product Packaging Materials
E-submission & dossier compilation in NeeS or eCTD format
- Converting an existing dossier to CTD format or creating a new dossier respecting the current guidelines
- Creation of an xml-backbone which is essential for lifecycle management
- Dossier validation according to the latest industry standards
Regulatory Affairs Strategic advice
- Managing Scientific-Technical Advice requests addressed to the European Medicines Agency EMA and the Europan national health authorities.
- Identification of appropriate regulatory strategies
- Hands-on experience to anticipate potential problems and seek out appropriate solutions
Want to know more / require a quote ?
Send your request to regulatory.affairs [at] archemin.eu