Our WDA Expertise
ProPharma is a leader in assisting clients to navigate the complex landscape of Wholesale Distribution Authorisation (WDA) requirements. Our expertise encompasses the full spectrum of services needed to obtain and maintain a WDA, ensuring compliance with the stringent regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD). We provide comprehensive support, including writing and refining Quality Management Systems (QMS), conducting thorough gap analyses, and performing vendor audits. Our team of experienced professionals delivers tailored training programs for employees and conducts mock inspections to prepare clients for regulatory reviews. With our robust understanding of Good Distribution Practice (GDP) principles and guidelines, ProPharma ensures that our clients meet all the necessary standards to achieve and sustain their WDA status.
ProPharma's Experience with WDA Applications
ProPharma has a proven track record of successfully guiding clients through the WDA application process and beyond. Our extensive experience includes supporting clients in applying for both human and veterinary WDA licenses, providing contract Responsible Persons (RP), Responsible Person import (RPi), and Wholesale Qualified Persons (WQP). We can also provide contract Qualified Person (QP) support to our clients either on their Manufacturers Import Authorisation (MIA) or under ProPharma’s MIAs. We have developed and implemented numerous Quality Management Systems (QMS) tailored to our clients' specific needs, ensuring compliance and readiness for regulatory inspections. Our team has fronted regulatory inspections on behalf of clients, delivering post-inspection remedial support to address any issues identified. With a commitment to excellence, ProPharma's experienced professionals have consistently enabled clients to achieve their WDA goals, maintaining the highest standards of quality and compliance.
What is a WDA (Wholesale Distribution Authorisation)?
What is a WDA (Wholesale Distribution Authorisation)?
Requirements prior to applying for a WDA (H) or WDA (V)
Requirements prior to applying for a WDA (H) or WDA (V)
What is a WDA (Wholesale Distribution Authorisation)?
A wholesale distribution authorisation (WDA) is a legal requirement for any company that stores or distributes human or veterinary medicines in the UK. A WDA is also known as a “wholesale dealer licence” or a “wholesale dealer authorisation”, and it replaces the previous term of wholesale dealers’ licence (often called WDL or WL).
There are different types of WDA available depending on the nature and scope of the distribution activities.
A WDA can cover both licensed and unlicensed medicines, as well as investigational medicinal products (IMPs) for use in clinical trials, depending on the scope applied for in the application.
For example, a WDA (H) is for medicines for human use, a WDA (V) is for medicines for veterinary use, and a WDA (IMP) is for investigational medicinal products.
How can ProPharma assist you in obtaining a WDA?
PropPharma has assisted many clients to obtain their own WDA (H) and WDA (V) including the following activities:
- writing their Quality Management System (QMS)
- conducting a gap analysis on their current QMS and undertaking remediation support
- auditing their vendors
- GDP training of employees
- undertaking mock inspections and recalls
- applying for their WDA licenses
- providing contract Responsible Person’s (RP), responsible Person import (RPi) and contract Wholesale Qualified Person’s (WQP)
- providing contract quality managers
- fronting the regulatory inspection for the client
- providing post inspection remedial support
ProPharma has extensive experience in developing Quality Management Systems (QMS) to support clients to apply for their own WDA (H) or WDA (V) and overseeing their regulatory inspection.
We have registered Qualified Persons and Responsible Persons who are eligible to act a RP, RPi or WQP on our clients’ WDA (H) or WDA (V).
WDA Experts
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David Crome
Managing Director, Quality & Compliance UK & India
View Bio
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Alexis O’temro
Associate Director, Quality & Compliance
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Ruth Buchanan
Associate Director, Quality & Compliance
View Bio
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Saket Jadhav
Quality Assurance Consultant
View Bio
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