As your professional peptide partner, we maintain Regulatory Affairs departments in both the United States and Europe to address issues affecting your product in specific countries as well as globally. International harmonization of our Quality Assurance and Regulatory Affairs departments ensure that your NCE can be compiled and filed with full compliance at all international locations.
Among our accomplishments, we are proud to have participated in the approval of over 20 Active Pharmaceutical Ingredients (APIs) worldwide. Since its inception in 1996, The Group has successfully undergone more than 10 FDA Pre-approval and Site inspections.
Among our many resources and services:
- FDA-compliant cGMP facilities
- Chemistry, Manufacturing and Controls (CMC) Documentation in Common Technical Document (CTD) format for INDs
- Drug Master File (DMF) Compilation
- Representation at the FDA and/or other Regulatory Authorities
GMP Services Included
GMP manufacturing requires considerable documentation and regulatory support. All GMP peptide projects at the PolyPeptide Group include a complete “price included” service package. This covers all the services needed to reach approval of your API.We are an active partner in your project's success.
Our GMP Service Package includes:
- All GMP manufacturing procedures
- Process development
- Preparation and characterization of an in-house reference standards
- In-house impurity reference standards
- Analytical methods development and characterization
- Analytical methods validation
- Full stability testing according to ICH guidelines (over 4 years at storage temperature)
- Process validation
- All batch documentation and any support documentation required, including a CMC/IND package and a US or European DMF as needed
- Support with regulatory agencies
Our Standard GMP Specifications include:
- Appearance
- Solubility
- Identity (via mass spectral analysis, amino acid analysis
- and HPLC)
- Peptide purity (HPLC)
- Related substances (HPLC)
- Assay (peptide content)
- Counterion content
- Moisture content
- Mass balance
- Trifluoroacetic acid
- Residual organic solvents
- Bioburden
- Endotoxin
- Other API-specific parameters
PolyPeptide Laboratories A/S