Responsible Person (RP) Services

Certified Experts for Compliance and Quality Control

Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the EU require an 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 RP 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. Learn about the responsibilities and criteria of a responsible person within the pharmaceutical industry. For expert guidance, contact us to learn about our RP services or read about them below.

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Responsible Person Services for Wholesaling of Medicinal Products and Active Pharmaceutical Ingredients Under GDP

Wholesaling is a key factor for drug manufacturers and Marketing Authorization Holders to ensure the supply of pharmaceutical products to their customers at pharmacies and hospitals. Wholesaling of pharmaceutical products is done in accordance with the GxP-standard Good Distribution Practice (GDP).

Each Wholesaler Dealer Authorization (WDA) has a Responsible Person (RP) named on the license. The RP has the quality oversight of the company’s wholesale operation and has the main responsibility to assure compliance with GDP-regulations and that the quality of the products distributed is maintained. The exact requirements for an RP are set in the national legislation, but in general, it is a degree in Natural Science/Pharmacy and relevant experience from GDP required.

Our highly experienced RPs can act as contractors named on your, or a third party’s Wholesale Dealers Authorization for both human and veterinary medicines under European Guidelines 2013/C 343/01 human medicines and 2015/C 95/01 APIs for medicinal products for human use.

Our Responsible Person Services

  • Partner with your organization to lead or assist in obtaining the wholesale distributor authorization (WDA) including named Responsible Person.
  • Responsible Person for Importation (RPi) for UK-based WDAs.
  • Building GDP/WDA Quality Management Systems (QMS).
  • Obtaining national licenses for controlled substances (narcotics) including import/export authorizations
  • Support in the establishment of a legal entity (required for obtaining a WDA)
  • Providing strategic recommendations in addition to standard RP oversight. We will support your organization to reduce issues, delays, and costs in the supply chain.
  • 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 RP and back-up RPs for each assignment, delivering full continuity, and reduced risk.
  • Providing full oversight of the QMS to maintain product quality for distribution to pharmacies, hospitals, and/or other wholesalers.
  • Train staff in GDP-regulation
  • Oversight of PQC, recall and return processes
  • EU-serialization support including contracts and management of EMVO and NMVOs
  • GDP-self inspections
  • Qualification of supply chain vendors
  • Review and negotiate Quality Technical Agreements (QTA)
  • Storage and distribution warehouse auditing to GDP.
  • Supply chain oversight:
    • Route mapping
    • Transport risk assessments
    • Transport validations
  • Special product experience:
    • Cold storage/distribution (2-8 degrees and frozen)
    • Controlled substances
    • Sensitive products
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Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.

We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.

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