Regulatory Services

Regulatory Document Preparation

FreeThink can conduct your study and help with regulatory document preparation with the health authorities, to speed entry into clinical trials and to enable faster market introduction of new and generic drug products.

FreeThink can support the preparation of Common Technical Document (CTD) IND/IMPD, NDA, and MAA sections related to stability and shelf life justification, including, but not limited to drug substance sections under S.7 and drug product sections under P.8.

FreeThink offers help with completing modules in the CTD for investigational (IND/IMPD), commercial, and post-approval change submissions (such as SUPAC) for NDA and ANDA products. This includes the Quality (CMC) sections for the submission captured in ICH M4Q, and sections related to stability data and shelf life justification which generally fall under the Quality sections of the CTD as follows: Drug Substance (3.2.S.7 Stability) and Drug Product (3.2.P.8 Stability).

Did you know…?

Clinical use periods have been accepted by health authorities using just ASAPprime® modeling.

Learn more here.