Our Services
End-to-end regulatory and quality support for every stage of the peptide product lifecycle.
Quality Management Systems
We design and implement complete quality management systems tailored to peptide manufacturing and distribution operations. Whether you are launching from scratch or remediating an existing program, our QMS frameworks are built to satisfy FDA 21 CFR 210/211, ICH Q10, and applicable USP chapter requirements.
- Quality policy and organizational structure
- Document control and records management
- CAPA and deviation management systems
- Management review and continuous improvement
- Supplier qualification programs
SOP Template Packages
Our flagship offering: a library of 60+ standard operating procedures covering every functional area of a peptide operation. Each SOP is mapped to applicable regulations, formatted for immediate use, and designed for easy customization to your specific processes.
Manufacturing
Batch production, process validation, equipment qualification, environmental monitoring, and cleaning validation procedures.
Quality Control
Analytical testing, method validation, stability programs, out-of-specification investigations, and laboratory controls.
Distribution
GDP-compliant storage, cold chain management, DSCSA serialization, transport validation, and customer complaint handling.
Regulatory Strategy & Submissions
Navigating the peptide regulatory landscape requires specialized knowledge of compounding law, FDA registration pathways, and international filing requirements. We provide strategic guidance on 503A and 503B pathway selection, FDA facility registration, Drug Master File preparation, and international market access.
Post-Market Surveillance & Pharmacovigilance
Compliance does not end when a product ships. Our post-market programs include adverse event reporting systems, MedWatch submission support, signal detection methodologies, periodic safety reporting, and risk management frameworks that satisfy FDA expectations and protect patients.
Audit Preparation & Remediation
Be inspection-ready at all times. We conduct mock FDA inspections, gap analyses against current regulations, and provide remediation plans with prioritized timelines. Our team has hands-on experience with FDA Form 483 responses, Warning Letter remediation, and third-party audit preparation.
Need a Custom Solution?
Every peptide operation is unique. Contact us for a tailored compliance package.
Current Peptide Compliance 