Built-In Excellence. Delivered With Every Batch.

At MedPharm, quality and compliance are embedded in every stage of pharmaceutical development and manufacturing. From early formulation through commercial supply, our approach ensures your product meets global regulatory expectations with consistency, control, and confidence.

As a science-led CDMO, our integrated Quality Management System (QMS), GMP-compliant facilities, and expertise across FDA, EMA, MHRA, and global requirements enable us to deliver reliable data, robust processes, and inspection-ready programs.

Quality That Supports Every Stage

MedPharm’s quality framework is designed to support:

• Regulatory alignment across global markets
• Inspection readiness with clear, auditable documentation
• Batch-to-batch consistency and reproducibility
• Data integrity and full traceability
• Continuous improvement through internal and external audits

Whether supporting early development or commercial manufacturing, our systems ensure scientific integrity and product reliability.

Built on Proven Systems and Standards

GMP
GMP Compliance
All manufacturing, packaging, and QC testing activities are conducted under GMP and ICH guidelines, supported by validated processes and controlled environments.

Global Regulatory Support
Global Regulatory Expertise
We support regulatory submissions and inspections for the FDA, EMA, MHRA, and other international authorities, helping you prepare for audits, pre-approval inspections, and regulatory queries.

QMS
Integrated Quality Management System
Our centralized QMS governs operations across our UK and US sites, supporting:

• Change control and deviation management
• Document control and SOP governance
• CAPA and risk management processes
• Internal and external audits
• Vendor qualification and oversight

Training
Qualified Teams and Ongoing Training
Our teams are trained on current regulatory requirements, quality systems, and safety practices, ensuring consistent execution across all programs.

Inspection Readiness and Regulatory Confidence

Recent FDA Inspections
MedPharm maintains a strong track record of regulatory inspections. Our Durham, NC facilities recently completed an FDA inspection with a No Action Indicated (NAI) classification and no Form 483 observations.

This reflects a disciplined approach to quality, with a focus on right-first-time execution, transparency, and operational control.

Aligned with Your Development and Commercial Goals

Whether you are preparing for pre-IND/Scientific advice or IND/IMPD activities, advancing toward ANDA, NDA, MAA, or 505(b)(2) submissions, MedPharm’s quality team supports your program across global regulatory pathways through:

• Regulatory strategy support, both internally and in collaboration with partners
• Quality oversight for scale-up, validation, and tech transfer
• Audit and inspection readiness support
• Batch review and release activities
• Regulatory documentation and CMC contributions
• Analytical method qualification and validation support

A Partner You Can Rely On

We operate as an extension of your team, ensuring quality is built into every decision, process, and deliverable. The result is a program that is not only compliant, but positioned for regulatory success from the start.