BCN Peptides S.A.
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Regulatory Affairs Services
BCN Peptides brings together a legacy of experience in successfully managing the complex regulatory and registration processes required for peptides. In addition to compiling and submitting regulatory documents for pharmaceutical substances in Europe, US and Japan, BCN Peptides also has extensive regulatory experience worldwide.
Our Regulatory Affairs team has experience in writing different types of regulatory dossiers, such as:
- Drug Master Files
- IMPD/IND
- EP-Certificates of Suitability (CEP)
- Regulatory Support
As required we support approvals of our contracted customers' NDAs and MAAs during registration as well as post-approvals through response to questions issued by the authorities.