Regulatory Issues Print E-mail
Through our previous work in large pharma and contract manufacturing, we have developed a wide expertise in CMC issues (Chemical Manufacturing and Control) and this, of course, includes regulatory advice on issues such as cGMP, choice of regulatory starting material, specifications and quality control issues, batch records, process deviations etc.  We have written the CMC section for regulatory documents.  We also have access to more detailed regulatory expertise through our associate consultants.

We have audited CROs and CMOs for our clients not only for regulatory compliance but also for technical ability to meet targets and deliver the goods on time, within specification and to an agreed cost

One of our consultants writes the Regulatory Highlights for the journal OPR&D and keeps up-to-date with recent changes in legislation, both in USA and Europe.