cGMP Support

Valli Consulting AB has over 10 years of experience working under the current Good Manufacturing Practice (cGMP) regulations, ISO regulations and ICH guidelines. Our consultants have more than six years hands-on responsibility for the quality systems within the QC laboratories of Pfizer Health AB in Uppsala, Sweden.

Our consultants have experience from participating in, and hosting, several quality inspections by regulatory authorities and other enforcement agencies, which includes the Swedish Medical Products Agency and the US Food and Drug Administration (FDA). We have also participated in inspections of incoming material suppliers. On several occasions, we have lectured on cGMP issues, including 21 CFR Part 11 for electronic systems.

Valli Consulting AB can assist and advice on setting up and maintaining quality systems, including topics such as documentation practices, change control and deviation management.

We provide a one-stop venue for our value adding services, from preparation of  inspections, providing assistance and advice during regulatory authority inspections, perform pre-inspections, provide training on cGMP and other quality regulations, to the ultimate design and improvement on customer's quality systems.