Quality & Certifications
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.
ISO 9001:2015
EU GMP Certified
FDA Registered
ICH Q7 Compliant
REACH Compliant
USP/EP Methods
Certifications
Our Regulatory Certifications
& Compliance Standards
Click any certification to view full details, scope, and highlights. Certificates are available upon request for qualified customers.
ISO 9001:2015
ISO 9001:2015
Bureau Veritas
Cert No: BV-QMS-2023-04821
Issued: March 2023
Expires: March 2026
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
EU GMP Annex 11
EU GMP Annex 11
European Medicines Agency (EMA)
Cert No: EMA-GMP-2022-EU-7734
Issued: January 2022
Expires: January 2025
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
FDA Registration
FDA Registration
U.S. Food & Drug Administration
Cert No: FDA FEI #3012345678
Issued: Ongoing
Expires: Biennial Renewal
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
ICH Q7 Compliant
ICH Q7 Compliant
International Council for Harmonisation
Cert No: Third-party audited
Issued: Verified 2023
Expires: Ongoing
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
REACH Compliant
REACH Compliant
European Chemicals Agency (ECHA)
Cert No: ECHA REACH Reg. #01-2119-XXX
Issued: 2019
Expires: Ongoing
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
USP / EP Methods
USP / EP Methods
Pharmacopeial Standards
Cert No: USP & EP Compendial
Issued: Ongoing
Expires: Updated Annually
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>
Quality Management System
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.
01
Raw Material Receipt
02
Incoming QC Testing
03
Material Release
04
Synthesis & Production
05
In-Process Controls
06
Final QC Testing
07
QP Batch Review
08
CoA Issuance & Shipment
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.
Incoming QC
No raw material enters production without passing our incoming QC program. Every supplier is qualified, and every lot is tested against approved specifications before use.
In-Process Controls
Critical process parameters are monitored in real-time throughout synthesis. Intermediate checks ensure any deviation is caught and addressed before it affects final product quality.
Final Release Testing
Every batch undergoes a comprehensive final release testing panel. No product ships without a fully reviewed and approved Certificate of Analysis signed by our QP.
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
CoA Reports
Certificate of Analysis
Batch Reports
Contact us for batch-specific documentation for the listed products. No batch reports have been supplied for this catalog.
Document Center
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)
5 samples
GMP
Semaglutide
99.4%
Preview
GMP
Tirzepatide
98.9%
Preview
Research
BPC-157
98.2%
Preview
Research
TB-500
97.8%
Preview
Research
CJC-1295
98.5%
Preview
Quality Certificates
4 documents
Analytical Methods
4 documents
Regulatory Documents
4 documents
Need a specific document?
If you need a document not listed here — such as a batch-specific CoA, stability data, or regulatory submission package — contact our QA team directly.