Strategic consultation in the areas of:
Content and defense of regulatory submissions to US, Canada, UK, Europe and Asia
Meetings with regulatory agencies (scientific advice, preIND, end of PII/PIII, preNDA)
Drug substance and drug product specifications and control strategies
Analytical characterization, methods development and validation
Due diligence and business development activities
We also offer customized workshops and training on chemistry, manufacturing and controls of oligonucleotide therapeutics.