Uncompromising Quality
At Every Step
From raw material sourcing to final product release, every batch undergoes rigorous analytical testing and full GMP documentation — so you can trust every peptide we deliver.
Our Regulatory Certifications
& Compliance Standards
Click any certification to view full details, scope, and highlights. Certificates are available upon request for qualified customers.
Quality Management System for Peptide Synthesis, API Manufacturing, and Distribution
- Full lifecycle QMS from raw material to final release
- Annual surveillance audits by Bureau Veritas
- Document control and CAPA management system
- Supplier qualification and incoming QC program
Good Manufacturing Practice for Active Pharmaceutical Ingredients — Computerised Systems
- Electronic batch records with full audit trail
- Validated computerised manufacturing systems
- Environmental monitoring and cleanroom certification
- Validated cleaning and sterilisation procedures
API Manufacturer Registration — Active Pharmaceutical Ingredients for U.S. Market
- Registered API manufacturer for U.S. IND/NDA supply
- Pre-approval inspection (PAI) readiness maintained
- Drug Master File (DMF) support available
- 21 CFR Part 211 compliance documentation
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Full ICH Q7 chapter compliance mapping
- Third-party gap analysis completed 2023
- Change control and deviation management
- Stability program per ICH Q1A guidelines
Registration, Evaluation, Authorisation and Restriction of Chemicals — EU Regulation
- All substances registered with ECHA
- Safety Data Sheets (SDS) available for all products
- Substance of Very High Concern (SVHC) screening
- Supply chain communication compliance
Analytical Testing per United States & European Pharmacopeia Compendial Methods
- HPLC methods validated per USP <621>
- Endotoxin testing per USP <85> LAL method
- Reference standards traceable to NIST
- Residual solvents per ICH Q3C / USP <467>
How We Guarantee
Quality at Every Stage
Our ISO 9001 and GMP-compliant Quality Management System covers every step of the manufacturing process — from supplier qualification to final product release.
Document Control
Every procedure, specification, and record is controlled, version-tracked, and accessible through our validated EDMS — ensuring full traceability from raw material to final release.
- SOPs for all manufacturing and QC operations
- Electronic document management system (EDMS)
- Version-controlled batch manufacturing records
- Change control with impact assessment
- Deviation and CAPA management workflow
Certificate of Analysis
Batch Reports
Every batch ships with a full CoA. Below are reports from recent GMP and research-grade batches — showing the level of analytical detail we provide.
Semaglutide
Analytical Test Results
| Test | Result | Specification | Status |
|---|---|---|---|
| HPLC Purity | 99.4% | ≥99.0% | PASS |
| Molecular Weight (MS) | 4113.6 Da | 4113.58 ± 0.5 Da | PASS |
| Amino Acid Analysis | Conforms | Conforms to sequence | PASS |
| Endotoxin (LAL) | 0.42 EU/mg | < 1.0 EU/mg | PASS |
| Residual Solvents | < ICH Q3C limits | ICH Q3C Class 2 | PASS |
| Water Content (KF) | 4.8% | ≤ 8.0% | PASS |
| Optical Rotation | -28.6° | -25° to -32° | PASS |
| Peptide Content (AAA) | 96.2% | ≥95.0% | PASS |
Quality Documents
& Downloads
Access our quality certificates, analytical methods, and regulatory documents. Restricted documents are available to qualified customers upon request.
Sample Certificates of Analysis (CoA)
Quality Certificates
4 documentsAnalytical Methods
4 documentsRegulatory Documents
4 documentsIf you need a document not listed here — such as a batch-specific CoA, stability data, or regulatory submission package — contact our QA team directly.