You have already identified problems in your operations?
Costs have increased, first-past-success-rates are down?
Products had to be recalled?
You are facing submission of an NDA or EU marketing authorisation and there is still something to be improved in your pilot plant?
Your customers have cancelled contracts due to GMP findings?
Regulatory authorities have raised concerns?
The FDA left a quite long list of 483’s or a warning letter awaiting reply?
Someone is copying your products?
We cannot promise to solve your problems overnight. But we can set up a program to achieve a “defendable level of compliance” as soon as possible and we stay with you and your team until this level is reached.