At Zeptide Pharma, our commitment extends beyond laboratory setup and peptide synthesis training. We specialize in providing comprehensive technical education on Certificate of Analysis (CoA) validation, ensuring your team can independently verify the quality and purity of every batch produced.
Streamlined Regulatory Submissions & Compliance Documentation
We simplify the complexities of the pharmaceutical supply chain by providing a robust quality compliance package. Our turnkey systems are designed to automate and generate the vital peptide documentation required for global regulatory approval. Every manufacturing run is backed by:
- Analytical Data Sheet (ADS): Comprehensive technical data for every sequence.
- Certificate of Analysis (CoA): Full transparency on validated QC metrics and peptide batch characterization.
- Raw Material Traceability: Detailed reports ensuring full oversight of the production lifecycle
Audit-Ready Quality Assurance for Medical Devices & Pharma
To meet the rigorous standards of medical device manufacturing and clinical research, we provide essential safety certifications and specialized technical support, including:
- TSE/BSE-Free Certification: Guaranteed animal-origin-free validation to meet international safety standards.
- ISO 13485 & GMP Compliance: We provide the framework for audit-ready workflows, ensuring your facility remains compliant under the strictest inspections.
- Regulatory Support Files (RSF): Expertly prepared documentation to assist in your filing processes.
- Medical Device File (MDF) Support: Provision of specialized technical files for integration into clinical-grade medical device applications.
Technical File Excellence
Our training and support systems ensure your Quality Management System (QMS) has the technical file support needed to navigate the FDA, EMA, and ISO regulatory landscapes with confidence. From initial synthesis to final regulatory submission, we ensure your peptide manufacturing process is fully documented, validated, and ready for market.