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