Certified Experts for Compliance and Quality Control
Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the EU require a MIA license and a designated Qualified Person (QP) and Responsible Person (RP), to oversee the product quality throughout the quality assurance (QA) process.
Acting as an extension of your organization, our QA consultants bring a deep understanding of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) processes. They work with your team to ensure compliant manufacturing and distribution of products in the EU market.
Specialized QP/RP Services
ProPharma Group’s global team of certified experts have broad experience covering multiple types of formulations, complex supply chains, technical transfer projects, aseptic/sterile manufacturing, radiopharmaceuticals, biologics, market access, and supply for clinical trials.
Our QP/RP services include:
- Partnering with your organization to lead or assist in obtaining the manufacturer’s import license and wholesale distributor license
- Building Quality Management Systems (QMS)
- Providing strategic recommendations in addition to standard QP oversight. We will support your organization to reduce issues, delays, and costs in the manufacturing process
- Helping organizations develop a flexible staffing model that caters to specific needs ranging from long-term lead assignments (named on the client’s license) to interim support
- Providing around the clock support, enabled by at least two QPs per assignment, delivering full continuity, and reduced risk
- Providing full oversight of the QMS to maintain product quality in the distribution to pharmacies, hospitals, or other wholesalers