Gap Analysis 

TRIPHASE provides drug product development consulting services in the area of regulatory compliance gap analysis of product development plans and submissions.

Regulatory Preparation and Representation

We help prepare for and/or participate in regulatory authority meetings including developing meeting information packages and responses to regulatory requests from pre-IND to pre-approval inspections (PAI) and post-approval requirements.

Regulatory Filings

TRIPHASE regulatory experts can plan, manage, review, write and submit in eCTD compliant format technical sections and summaries for regulatory filings, including IND, IMPD, orphan drug designation applications, amendments, CTA, NDA, ANDA, DMFs,  Investigator’s Brochure (IB), annual reports, amendments, etc. We have supported development and commercial submissions in the US, Canada, Asia and Europe.Creative concise scientific writing:  Our CEO is a published literary author as well as author of over 30 scientific publications and patents.  He knows how to present your science concisely and in the best light to support your goals gained from writing over 50 regulatory filings.

US Agent Services

We can act as the US Agent for US-based regulatory submissions from non-US sponsors
Regulatory compliance Q7A, 21 CFR Parts 210-211 and ICH compliance