GMP manufacturing requires considerable documentation and regulatory support. All GMP peptide projects at Bio-Synthesis Laboratories include a complete service package pricing which includes all the services needed to reach approval of your API.

Among our many resources and service we provides:

• FDA-compliant cGMP facilities
• Chemistry, Manufacturing and Controls (CMC) Documentation in Common Technical Document (CTD) format for INDs
• Drug Master File (DMF) Compilation

Our GMP Service Package includes:

GMP manufacturing requires considerable documentation and regulatory support. All GMP peptide projects at Bio-Synthesis Laboratories include a complete service package pricing. This covers all the services needed to reach approval of your API. All GMP manufacturing procedures Preparation and characterization of an in-house reference standard In-house impurity reference samples Analytical development and characterization Analytical 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 Support with regulatory agencies

Our Standard GMP Specifications include:

Mass Spectral Analysis Amino Acid Analysis (AAA) Sequencing RP-HPLC Residual Organic Volatiles Bacterial Endotoxin Evaluation Bioburden Evaluation   Net Peptide Content by AAA Counter Ion Content (Acetate, Trifluoroacetate, Hycrochloride and more) Secondary Counter Ion Content Appearance Solubility water content Mass Balance Calculation