Quality & Compliance
Built-In Excellence. Delivered With Every Batch.
At MedPharm, quality is not an afterthought—it’s a foundational principle that shapes every process, decision, and deliverable. From early formulation through commercial manufacturing, our commitment to Quality & Compliance ensures your drug product is developed and produced to the highest regulatory, scientific, and ethical standards.
With a fully integrated Quality Management System (QMS), GMP-compliant facilities, and deep expertise in FDA, EMA, MHRA, and global requirements, we deliver more than data and materials—we deliver trust.
Our Commitment to Quality
MedPharm’s robust quality framework is designed to support:
- Regulatory alignment across global markets
- Inspection readiness and transparent documentation
- Batch-to-batch consistency and reproducibility
- Rigorous data integrity and traceability
- Continuous improvement through internal and client-driven audits
Whether we’re developing an early-stage prototype or producing commercial supply, our quality culture ensures scientific integrity, product safety, and client peace of mind.
Key Elements of Our Quality Approach
Good Manufacturing Practice (GMP) Compliance
All manufacturing, testing, and clinical supply activities are conducted under GMP and ICH guidelines, supported by validated processes and controlled environments.
Global Regulatory Expertise
MedPharm supports submissions and inspections for the FDA, EMA, MHRA, and other international authorities. We stay current with evolving standards to help you navigate audits, pre-approval inspections (PAIs), and regulatory queries with confidence.
Integrated Quality Systems
Our centralized QMS governs every function across our UK and US operations, with systems for:
- Change control and deviation management
- Document control and SOP governance
- CAPA and risk assessment workflows
- Internal and external audits
- Vendor qualification and oversight
Qualified Personnel & Ongoing Training
Our teams are continuously trained on the latest regulations, quality practices, and safety procedures—ensuring a culture of compliance at every level.
Aligned with Your Risk, Regulatory, and Commercial Needs
Whether you’re preparing for an ANDA, NDA, MAA, or 505(b)(2) submission, MedPharm’s quality team acts as a seamless extension of your own. We provide:
- Quality oversight for validation, scale-up, and tech transfer
- Support for QMS audits and regulatory inspections
- Batch release review and certification
- Regulatory documentation and CMC section contributions
- Analytical method qualification and validation support
Quality Is Our Reputation—And Yours
When you work with MedPharm, you gain a partner who treats your product like it’s our own. Our commitment to right-first-time execution, full transparency, and regulatory excellence ensures your product is built on a foundation of trust.
Experience the MedPharm standard of quality—because compliance isn’t optional, it’s expected.
Audit & Inspection History
At MedPharm, regulatory excellence is integral to our operations. From early-stage development to GMP clinical and commercial manufacturing, our commitment to Good Manufacturing Practice (GMP) ensures that we deliver safe, effective, and high-quality products that meet or exceed global compliance standards.
Certifications
MedPharm operates under fully certified, audit-ready systems across our U.K. and U.S. sites. Our facilities, personnel, and quality programs meet the rigorous standards of national and international authorities—and we welcome partner audits as a part of transparent, collaborative relationships.
Quality Assurance
At the heart of MedPharm’s development and manufacturing excellence is a deeply embedded Quality Assurance (QA)culture. Our QA team operates independently yet collaboratively across functions to ensure all processes are executed correctly, documented thoroughly, and reviewed against the most current standards.
Regulatory Standards
At MedPharm, we develop and manufacture drug products with full alignment to the world’s leading regulatory authorities, including the FDA, EMA, MHRA, and other global health agencies. From early-stage planning to final submission and post-approval support, we ensure that every formulation, process, and document meets the standards necessary for approval—wherever you’re going to market.
Supply Chain Resiliency
Pharmaceutical supply chains have faced unprecedented scrutiny and heightened expectations. Even before the COVID-19 pandemic exposed global vulnerabilities, the industry was already grappling with whether globalization has compromised supply chain resilience.
