We Provide a Variety of CMC Services such as...

Global Strategic Consultation for all phases of development for IND, IMPD, NDA, CTA, BLA, ANDA, Cosmetic and OTC Monograph drugs.
Author, review and compile original IND, IMPD, CTA, NDA, BLA, ANDA, MAA Applications, as well as DMF, Agency Query Responses, Amendment, Annual Report, Product License Renewal, NDA Supplement, EU Variations (Type 1A/1B, Type 2 and Extension) and ROW.
Prepare Agency Meeting Requests, Briefing Book and facilitate client meeting preparation.
Prepare Gap Analyses on submission dossiers.
Liaison with Regulatory Health Authorities.
Prepare and Review labeling components for Cosmetics in addition to Drug Facts labeling for NDA OTC and Monograph Drug Products.

Providing Outstanding Regulatory CMC consultation Services to Fortune 100, Mid-Size and Small Companies Over the Past Two Decades..