A successful registration, based on transparent communication, not only permits entry to markets all over the world; it also confirms that Heraeus meets the strictest requirements for the quality of its APIs.
Preparation of Dossiers
- registration documents according to current ICH standards
- all relevant pharmacopeias (e.g. Ph. Eur., BP, USP, JP, IP, CP)
- chemical-pharmaceutical dossiers (CMC, Module 3): technical writing of the complete part - also based on customers’ raw data
- CEPs available for all APIs with a pharmacopeial monograph
- expertise in eCTD submissions and non-eCTD electronic submissions (NeeS)
Management of Registration Procedures
- registration procedures consistent with current guidelines and predetermined timeframes
- assistance in providing additional technical information
- competent personal contact at all stages of the registration process
Life Cycle Management
- regulatory support for existing products
- continuous improvement of documentation
- established change control system
- professional change management with customers and authorities in line with the current Variation Regulations
