Strategic Quality Direction

If you don’t have experience, you need to have direction.

Sponsors developing Investigational Medicinal Products for clinical trial have the ultimate responsibility for product quality, safety, and efficacy.

This can be a daunting prospect if you are only just starting out on your GMP journey. Engaging consultants with appropriate subject matter expertise is important if you do not have the experience within your organisation.

JWQC can help you to determine your next steps and to evolve a quality system that provides vendor oversight, product oversight, and reduces risk, in a methodical way as we move through the clinical trial phases.

Training & Mentoring

Regular contact between Quality Representatives, CMC and QC representatives to review current work and risk, not only helps to determine next steps, but also provides a regular forum to mentor those less experienced. If you choose to transfer our ways of working to your own systems, we will provide the necessary training and oversight whilst you gain experience.

Pharmaceutical Quality Systems

We take a fresh look at your Pharmaceutical Quality System to help your organisation design straight forward, processed‑based systems. This might include self‑inspection, gap analysis and process mapping to design simple, risk‑based, pragmatic systems which are the key to successful quality outcomes.