During our various careers and through technical transfer consultancy projects we have direct experience of process validation. We keep abreast of the latest regulatory position and technologies that can be applied, for instance the support being given to Quality by Design and use of ‘real-time’ Process Analytical Technology by the regulatory authorities, to ensure correct advice in line with a changing environment. We have advised clients of critical process parameters prior to validating the process and on design space.
We are not a regulatory consultancy group, but through our previous work in large pharma and contract manufacturing, we have developed a wide expertise in CMC issues (Chemical Manufacturing and Control) and offer practical advice and guidance appropriate for the stage of development of a pharmaceutical. This 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 goods on time, within specification and to an agreed cost.
One of our consultants writes Regulatory Highlights for the journal ORP&D and keeps up-to-date with recent changes in legislation, bothin USA and Europe.