WDA Support

RP services and QA services to support your QMS

At MIAS, we offer expert WDA support to help our clients navigate the regulatory requirements and ensure compliance with all relevant guidelines. Our team of highly skilled professionals has extensive experience in obtaining and maintaining WDAs for a wide range of pharmaceutical products. 

We provide a comprehensive range of WDA support services, including assistance with the application process, preparation of the Quality Management System (QMS) and Standard Operating Procedures (SOPs), risk management, audit preparation, and ongoing support to ensure ongoing compliance with GDP guidelines. On request we can also provide RP services and QA services to support your QMS once it becomes operational to support you meet all your GMP & GDP requirements while maintaining a minimal presence.  

Contact us today on info@miaspharma.com learn more about how we can help you with your WDA needs and ensure compliance with all relevant regulations and guidelines. 

 

We offer expert WDA support to help our clients navigate the regulatory requirements and ensure compliance with all relevant guidelines

What is Wholesale Distribution Authorisation?

A Wholesale Distribution Authorisation (WDA) is required for any company involved in the distribution of medicinal products within the European Economic Area (EEA). Obtaining and maintaining a WDA can be a complex and time-consuming process, requiring a detailed understanding of the regulatory landscape and strict adherence to Good Distribution Practice (GDP) guidelines. 

An RP, or Responsible Person, is an individual who holds a key role within a pharmaceutical company that holds a Wholesale Distribution Authorisation (WDA). The RP is responsible for ensuring that the company complies with all regulatory requirements for the distribution of medicinal products and for maintaining a compliant Quality Management System

How MIAS Pharma can help?

MIAS has an international team of associates that can provide turnkey WDA support irrespective of EU market, local knowledge is essential while engaging with local authorities. We can also provide an independent Mock inspection by our in-house team of ex-regulatory inspectors should you want an independent assessment of your system to put your mind at ease your application will progress without any issues.  

Our goal is to provide our clients with the peace of mind that comes from knowing that their WDA is in good hands. We work closely with our clients to understand their specific needs and provide tailored solutions that meet their unique requirements. Get in touch with us today!

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