GMP Precision for Every Phase of Clinical Development 

In clinical development, every dose and every detail matters. At MedPharm, our Quality and Regulatory-Focused Manufacturing ensures that investigational products are produced with the same care, control, and compliance expected at the commercial stage.

As a specialist CDMO dedicated to topical and transdermal drug products, we bring extensive regulatory expertise and meticulous execution to every clinical batch. Whether you’re preparing for a first-in-human study or a Phase III pivotal trial, MedPharm provides manufacturing solutions built on reliability, transparency, and global regulatory alignment.

What We Offer

Our clinical manufacturing operations are designed for agility and precision, enabling seamless production of Investigational Medical Products (IMPs) under full GMP conditions.

Key capabilities include:

GMP Manufacturing for Topical and Transdermal Dosage Forms: Products such as semisolids, gels, creams, lotions, ointments, solutions, and suspensions.

Phase-Appropriate Manufacturing: Adaptable batch sizes and documentation practices tailored for Phase I–III requirements.

Scalable Equipment and Cleanroom Facilities: Purpose-built suites for clinical-scale production and technology transfer compatibility.

Full Quality Control Integration: On-site analytical testing, in-process monitoring, and batch release support.

Global Regulatory Compliance: Manufacturing practices aligned with FDA, EMA, MHRA, and other international standards.

Audit-Ready Documentation: Comprehensive batch records, validation protocols, and quality assurance oversight to support regulatory filings and inspections.

More Than Just Manufacturing—A Strategic Partner in Development

We understand that clinical supply manufacturing involves more than just getting products out the door. It’s about laying the groundwork for regulatory success and commercial readiness.

That’s why MedPharm’s manufacturing team collaborates closely with your formulation, analytical, and regulatory teams to:

• Mitigate Chemistry, Manufacturing, and Controls (CMC) risks early on
• Streamline documentation for Investigational New Drug Applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), and New Drug Applications (NDAs)
• Ensure seamless scale-up and future technology transfer
• Deliver on-time, audit-ready clinical materials

Why Choose MedPharm?

• Decades of experience in clinical-stage topical product manufacturing
• Nimble and responsive to sponsor timelines
• Exceptional quality assurance and regulatory support integrated into every project
• Transparent communication and collaborative problem-solving
• End-to-end integration with formulation development and analytical services

Manufacturing That Moves You Forward

Your clinical program deserves more than basic GMP compliance; it deserves a manufacturing partner that prioritizes quality, regulatory alignment, and patient impact.