At Zeptide Pharma, we do more than design and commission peptide manufacturing labs and train staff in synthesis workflows —
we deliver integrated Regulatory Affairs and Quality Assurance training that equips your organization to move from preclinical work through regulatory submission and commercial launch.
What we provide
- Embedded RA & QA expertise: leverage decades of global cGMP peptide manufacturing experience and an integrated Regulatory Affairs and Quality Assurance organization that partners with your team to accelerate CMC deliverables and regulatory milestones.
- CMC-focused training and support: practical instruction on preparing robust Chemistry, Manufacturing and Controls documentation, risk assessments, regulatory strategy, and dossier-ready data packages mapped to international requirements.
- World‑class quality infrastructure: access to a dedicated QA/QC team that manages end‑to‑end product lifecycle oversight, change control, deviation/CAPA management, and audit readiness.
- Advanced analytical and stability capabilities: comprehensive impurity profiling, ICH-compliant accelerated and real‑time stability studies, and development/qualification of certified reference standards to support release criteria and shelf‑life claims.
- Quality by Design (QbD) integration: training and implementation of QbD principles across analytical method development, process characterization, and validation to generate meaningful, validated data that underpin regulatory submissions.
- Documentation and validation support: creation and review of validated analytical methods, batch records, validation protocols (IQ/OQ/PQ), and regulatory‑grade technical documentation to safeguard your therapeutic program.
Working with Zeptide Pharma gives you both the physical manufacturing capability and the regulatory-quality competency — training, systems, and validated data — required to de‑risk development and streamline the pathway to approval.
Zeptide Pharma offers a full-service turnkey solution for organizations looking to establish world-class peptide manufacturing labs. Our end-to-end approach includes 24 months of post-operational support to ensure maximum research efficiency and the consistent production of high-purity custom peptides.
Precision Engineering for High-Yield Results
Whether your facility is dedicated to therapeutic peptide discovery, metabolic signaling research, or in vitro diagnostics (IVD), we design RUO and cGMP-compliant production facilities tailored to your specific technical standards. Our laboratory designs prioritize scalability, allowing you to move seamlessly from R&D to bulk peptide scale-up.
Expertise in Complex Peptide Chemistry
We provide the infrastructure and training necessary for advanced solid-phase peptide synthesis (SPPS) and sophisticated peptide modifications, including:
- Disulfide bridge formation and peptide cyclization.
- PEGylation for enhanced bioavailability.
- TFA removal services for sensitive biological applications.
- High-throughput peptide library synthesis.
Integrated Quality Management & Validation
Our facilities are engineered to support a rigorous Quality Management System (QMS). We equip your lab with state-of-the-art HPLC purification and mass spectrometry (LC-MS) validation suites to ensure every batch meets pharmaceutical-grade specifications.
A Full-Service CDMO Partnership
Beyond the build, Zeptide Pharma acts as your strategic CDMO partner. We facilitate everything from private-label peptide solutions to the production of specialized lyophilized peptide formulations. Our mission is to provide the hardware, regulatory framework, and scientific expertise required to deliver high-yield, customized peptides tailored to the modern pharmaceutical landscape.
To establish a Professional Partnership:
Contact MayMag Biologics (Formerly Tirzepatide Pharma / Zeptide Pharma)
Partner with a premier USA-based, FDA-registered 503B/506E CDMO and IND facility. As a leading sterile API manufacturer and large-scale industrial supplier, we provide comprehensive manufacturing solutions for a wide range of critical care and specialized therapeutics, including:
- Diabetic Care & Biosimilars: Insulin 70/30 pens, glargine, and advanced biosimilars.
- Injectables & Auto-Pens: Auto-injector medications and epinephrine delivery systems.
- Specialized Treatments: Weight-loss therapies, nasal sprays, and ophthalmic products.
- Essential Preparations: Sterile and bacteriostatic waters.
