Wholesale Distribution Authorisation (WDA) and GDP Certification
Pharmaceutical companies or marketing authorisation holders who market medicinal products which have been made by a third party require a wholesale distribution authorisation, or WDA.
Where a company does not hold a WDA (Wholesale Distribution Authorisation) but transports active substances and/or medicinal products they must do so in accordance with good distribution practices (GDP).
Good Distribution Practices (GDP) Certification for pharmaceuticals demonstrates your dedication to good distribution practices and quality in every aspect of your service.
RP-PS can undertake a GDP audit against both national and European regulatory guidelines to determine compliance, and where required, undertake a risk assessment, gap analysis and remedial action plan. We can further support in rolling out robust and sensible remedial actions to ensure continued compliance.
Our Strategic Support Services
-
Warehousing and Distribution Audits
We can provide comprehensive analysis and review of your Warehousing and Distribution Network, from data collection to full hands-on detailed project and action plans
-
Network design and Optimization
Implement a flexible and cost effective warehousing and distribution network
-
Carve in / Carve out projects Management
Investing or divesting? Our team with proven track records in such projects can provide end-to-end support and ensure a smooth transition
-
Warehousing and Distribution Tender management
Whether you are planning to challenge your current third party Logistics provider, or reaching a new territory, we can assist you in the process and identify the right partner for your needs
-
Change Management
Whether you are changing 3PL, implementing a new system, designing new processes, or fully developing new activities, change management process is critical to minimize disruptions