Quality Services
We have numerous experienced consultants who have dealt with all aspects of a properly functioning and efficient Quality Management System.
This experience was gained from working on numerous projects at Acorn Regulatory as well as previous industry experience in large pharmaceutical companies.
WDA & Responsible Person
As per the requirements of the EU Good Distribution Guidelines 2013/C/343/01, it is mandatory for all wholesale distributors to designate a Responsible Person who has oversight of distribution operations to maintain product safety and security. Outsourcing the services of the Responsible Person (RP) is a cost-effective way to meet the requirement for comprehensive oversight of supply chain activities.
Acorn Regulatory can assist at any stage of the process whether you are looking to obtain a WDA from the HPRA or if you require a Contract RP. We can nominate one of our experienced RP’s to be named on your company’s licence to ensure you are complying with the provisions of the EU Good Distribution Practices guidelines. Our RP’s have extensive experience in obtaining WDA’s, hosting HPRA inspections and liaising with many health authorities worldwide.
Quality Systems Support
An effective QMS is the backbone of all pharmaceutical companies. The QMS should cover the entire product lifecycle including:
- Pharmaceutical development
- Technology transfer
- Commercial manufacturing
- Distribution
- Product discontinuation
Whether you have a Manufacturing Importation License or a Wholesale Distribution Authorisation an effective Quality System is key. All our quality consultants have vast experience in developing and maintaining quality systems.
Testimonial
The staff you assigned to us over the years were simply brilliant! Honestly, from efficiency, attention to detail, quality of work, communication and professionalism, each of them displayed all of these. We really enjoyed working closely with your team”.
