Services Offered

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.