Every peptide batch is manufactured under strict cGMP protocols with comprehensive analytical documentation and full traceability.
Mand-peptide maintains the highest industry standards with certifications from leading global regulatory bodies.
FDA / EMA
Current Good Manufacturing Practice compliance for pharmaceutical peptide production. Regular audits by FDA and European Medicines Agency.
TUV SUD
Quality management system certification covering all aspects of peptide design, synthesis, analysis, and customer service.
BSI Group
Medical device quality management for peptides used in diagnostic and therapeutic device applications.
FDA
Drug Master Files registered with FDA for multiple peptide APIs, enabling streamlined ANDA/NDA submissions by clients.
IFANCA
Halal certification for peptide products ensuring compliance with Islamic dietary laws and manufacturing standards.
OU Kosher
Orthodox Union Kosher certification for all peptide products meeting strict kosher production requirements.
Our in-house analytical laboratory is equipped with industry-leading instrumentation for comprehensive peptide characterization.
Reversed-phase (RP-HPLC), size-exclusion (SEC), and ion-exchange (IEX) chromatography for purity analysis and impurity profiling.
ESI-LC-MS and MALDI-TOF MS for molecular weight confirmation, sequence verification, and impurity identification.
Quantitative compositional analysis after acid hydrolysis confirming theoretical amino acid ratios.
Accurate quantification by elemental analysis and UV spectrophotometry against certified reference standards.
Endotoxin (LAL), bioburden, sterility, and mycoplasma testing for GMP-grade products per USP/EP standards.
ICH Q1A-compliant long-term and accelerated stability testing programs with forced degradation studies.
Download our complete quality assurance documentation including certificates, SOPs, and analytical method summaries.