Qualified Person Experience
Investigational Medicinal Product Specialists
As a sponsor, you need assurance that your IMP has been manufactured to GMP and in accordance with commitments you have made to the regulator. We have the necessary experience and knowledge to provide Quality Oversight of manufacturing operations at all your manufacturing partners from API manufacture, IMP manufacture, testing and clinical trial packaging.
Our experience, for batch certification of your products, covers sterile and non-sterile dosage forms including liquids, semi-solids, capsules and tablets, plasmids and proteins, freeze dried and spray dried presentations, cell-based and biotech products, and medical devices.
You can use our wealth of experience in your organisation to facilitate training, mentoring and education of staff.
Our Specialist Quality Services include:
Vendor Qualification
Quality oversight of IMP manufacturers
GMP Audits
Provision of tools for a structured PSF to ensure IMP production is managed effectively
Examples of our work
Now, let’s talk:
Call: +44 (0) 7803 603041
Email: enquiries@jwqc.co.uk
Alternatively, ask a question on our contact page