At first you may think this is simply to perform the batch release function. When a Quality professional such as Paul Palmer or one of his colleagues works with your business, you can be sure to benefit more from the vast experience brought to the role.
Paul Palmer has been eligible to act as a Qualified Person under the permanent provisions since 2004. Support is available for all medicinal product dosage forms and if required their associated medical devices.
Experience across the board in solid dose, liquids and creams, non-sterile and sterile terminally sterilised or aseptic manufacture as well as biological products and radio pharmaceuticals are all accounted for.
Assistance in the preparation and application for a new site license (MIA).
Support when preparing for a regulatory inspection.
Help in attaining and maintaining an audit ready state to eliminate the last minute confusion prior to inspection.
Advice on issues such as good manufacturing practice, regulatory compliance, contract manufacture, cold chain, import, active pharmaceutical ingredients and sub-contracting.
Supplier auditing; API, excipient, contractors and suppliers.
Qualified Person batch release of manufactured and imported products.
Assistance in reviewing the requirements which need to be taken into account in order to consolidate product licenses across multiple countries.
Creation, maintenance and update of your pharmaceutical quality system for your manufacturing, supply and distribution of medicinal products.
At Paul R Palmer we find our clients benefit from the flexible approach we have to providing the resources they need to maintain regulatory compliance. There are a range of services we offer pharmaceutical companies individually or as a combined package. We can help you with:
Getting your first license
QP declarations for API manufacturers
Hosting a regulatory inspection
Commercial and clinical batch release
Carrying out compliance audits
Coaching and training in GxP
President at Ethylene Oxide Sterilization Association (EOSA)/Director of Gas & Heat Sterilization (J&J)
Paul is a very energetic enthusiastic individual always willing to step up to the challenges given to him.
Direktor at Radgivning
I had the pleasure of working with Paul in 2010. Paul is very easy to work with. He is very helpful and has a huge knowledge about pharmaceutical products.
Senior Manager, Qualified Person at Biogen Idec
Paul was a very skilled and knowledgeable colleague. I enjoyed the ability to discuss quality related issues with him, and take advantage of his great experience. Paul worked very independently and completed his tasks in a satisfactory manor. I can easily recommend Paul as a good and skillful colleague.