Quality and Regulatory Consultation
Paul Graham Pharma Consulting and associates have a vast pool of Pharmaceutical Quality and Regulatory knowledge available to you to tap into.
We have a good track record in assisting our clients with quality management system development and continuous improvement including integration of quality risk management into the quality system, performing risk assessments and reviewing systems to current requirements.
We can help with regulatory support such as preparation and submission of licence applications for manufacturer’s, importers and wholesalers followed by licence variation submissions. For Investigational Medicinal Products, we have experience in the preparation and review of Investigational Medicinal Product Dossiers (IMPDs) and MAA preparation and submission.
PGPC recently assisted 2 of our clients to achieve good regulatory outcomes for their businesses.
The first was to obtain a Marketing Authorisation (MAA) for a medical gas for CSTS Ltd. A PGPC regulatory affairs associate prepared the MAA and liaised with the MHRA during the submission and the licence was granted in January 2012. We also assisted in sourcing a Pharmacovigilence Service for the client.
Speaking about the service provided by PGPC, Gordon Lyon CSTS Ltd Managing Director commented ….
‘Without Paul’s assistance we probably would not have achieved our marketing authorisation. He offers encouragement, advice and leadership where necessary. Paul played an active role in the team, despite being only a consultant. He is realistic in his expectations and delegates only where necessary. I would recommend Paul to any organisation that needs support in their pharmaceutical operations’
View the other success story on the Responsible Person on Wholesaler’s licence Page here http://www.paulgraham-consulting.com/services/responsible-person-on-wholesaler-licence/