Customized Global regulatory strategy to get first-pass approval of your product

Clinical, Non-clinical, CMC and regulatory gap analysis

Regulatory approval pathway optimization

Labelling and AdPromo Support

Marketing Authorizations applications (US, Canada, China, Japan and ROW)

Preparation of IND, NDA, BLA regulatory filing

Prepare and attend meetings with FDA and other key individuals and assist with pre-IND and IND consuting for your program