We are specialists in CMC regulatory affairs of both APIs and drug products.
Territories covered: USA, EU, UK, Canada, Australia, Japan, Brazil, and Mexico. Please get in touch to discuss about our pharmaceutical services in other markets.
Our team can support you in the following:
API regulatory Affairs
- Regulatory dossier (US DMF, ASMF, CEP, eCTD) authoring for new products
- Life-cycle maintenance
- Regulatory strategy
- Change-control assessment
- DMF updates and annual reports
- Gap analysis
- CEP variations
- Responding to deficiency letters from regulatory authorities
Drug Product Regulatory Affairs
- Regulatory dossier (US, EU and eCTD) authoring for new products
- Life-cycle maintenance: Variations (EU and US) and annual updates
- Regulatory strategy
- Change-control assessment
- USFDA: Abbreviated New Drug applications (ANDA)
- EU: National, Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and Centralised Procedure (CP)
- Gap analysis
- Responding to request for information (RFI) from regulatory authorities
Biosimilars
Information to follow
Medical Devices
- Support for approval of new product
- Review of EU technical files
- GAP analysis
- IFU – Instructions for use
- Support MDR and IVDR regulation
- Labelling compliance
- UDI – Unique Device Identification
- Support for UKCA marking
- Preparation and management of technical documentation according to GSPR (General Safety and Performance Requirements)
- EU authorised representative service