Regulatory Affairs Service
piCHEM accompanies your drug development in every phase of an application from pre-IND/IMPD meetings to the final marketing authorization.
We provide proven experience in all submission procedures (CP, DCP, MRP, national procedures) to national and international authorities to support your application process.
In compliance with relevant regulations and laws (ICH, USP, Guidance for Industry, Ph. Eur., PIC/S) the regulatory support includes:
- Strategy development and guidance throughout the complete authorization process
- Preparation of CMC/ Quality documentation for IND/IMPDs (phase I to III)
- Filing of DMF/ASMF in eCTD format for NDA/MAA
- Submission of regulatory documents to the FDA, EMA and national authorities according to regulatory requirements (e.g. CESP portal)
- Provision of response documents
- Lifecycle management (dossier maintenance, PQRs, annual reports, post-approval changes and variations)