Helping you to deliver new medicines to patients
Consistently, reliably, safely
Once you have developed your new Active Pharmaceutical Ingredient and you are ready to take it to Clinical Trial you want to be sure that your manufacturing partners have the correct knowledge and competence.
It is important that they manufacture your Active Pharmaceutical Ingredient (API) and Investigational Medicinal Product (IMP) according to Good Manufacturing Practice and relevant regulations. Manufacturers must ensure that your needs and requirements are met in full.
So how can you be certain of this?
Our staff have worked in many Contract Manufacturing Organisations (CMO) and have implemented IMP Quality Management Systems. We have worked with manufacturers to support their resolution of quality issues and events. Our Qualified Persons (QPs) have a wealth of GMP experience to complement your technical knowledge. So, when you are looking for an organisation that understands your manufacturing needs, JWQC can assist you to make the right choices in your selection of manufacturing partners.
Our services to Sponsors include:
- Comprehensive GMP audit services for all stages of manufacture from API production, drug product manufacture and contract testing to secondary packaging and clinical labelling.
- Quality Oversight of manufacturing operations once manufacturing partners have been selected and manufacturing has commenced
- Tools to ensure your manufacturing sites have the correct and relevant source information in their Product Specification Files.