Our scientific foundation
Deep Expertise Across the Biologics Value Chain
From regulatory strategy to sterile fill-finish, MayMag Biologics combines scientific rigour with manufacturing excellence to deliver compliant, high-quality therapeutics.
Core Competencies
506(e) Outsourcing Facility Operations
Registered with the FDA as a 503B outsourcing facility, we operate under cGMP standards to produce patient-specific and non-patient-specific compounded biologics at commercial scale.
GMP-Compliant Manufacturing
Our Dallas and Garland facilities hold current Good Manufacturing Practice certifications, with rigorous SOPs governing every step from raw material receipt to finished product release.
Peptide Synthesis & Characterisation
Advanced solid-phase peptide synthesis (SPPS) capabilities with full analytical characterisation including HPLC, mass spectrometry, and amino acid analysis for purity verification.
Biologics & Biosimilar Development
Expertise in the development and manufacture of biosimilar GLP-1 agonists, insulin analogues, and peptide-based therapeutics with demonstrated pharmacokinetic equivalence.
Regulatory Affairs
In-house regulatory expertise spanning FDA 503B compliance, USP <797> and <800> standards, IND submissions, and ongoing post-market surveillance obligations.
Cold Chain & Sterile Logistics
End-to-end cold chain management for temperature-sensitive biologics, including validated 2–8°C and -20°C storage, qualified shipping lanes, and real-time monitoring.
Credentials & Certifications
Partner with a team that knows the science
Speak with our scientific and regulatory experts about your next programme.
Contact Our Team