What Is a Dossier Submission?

What Is a Dossier Submission?

Dossier Submission is a systematized procedure for gathering and submitting documentations to legal bodies to seek authorization of pharmaceuticals, medical devices, or healthcare items. Such dossiers show that a product has attained the necessary standards of quality, safety, and efficacy prior to becoming marketed or distributed in a particular country or region.

Purpose of a Dossier Submission

The main goal of dossiers submission is to be compliant with regulations. These submissions are authorized by regulatory bodies like FDA, EMA, WHO, or national drug authorities to ensure that a product is safe to be used by the population. A comprehensive dossier saves time to prepare it and saves time spent on approval of timeframes and regulatory requests or refuses.

Key Components of a Dossier A typical dossier submission includes the following sections:

1. Administrative Information
Application forms, licenses, labeling, packaging information, and manufacturer information are included in this section.

2. Quality (CMC) Documentation
It describes Chemistry, Manufacturing as well as Controls (CMC) containing raw material, production process, specifications, stability tests, as well as quality control measures.

3. Non-Clinical Data
Non-clinical research like data regarding toxicology and pharmacology are provided to show product safety.

4. Clinical Data
Queries or rejections Clinical trial outcomes, bioequivalence or therapeutic efficacy information is provided to demonstrate product efficacy in humans.

Types of Dossier Formats The regulatory authorities can demand or request dossiers to be in standardized formats e.g.

• Common Technical Document (CTD).
• eCTD (Electronic Common Technical Document)
• Common Technical Dossier of the ASEAN (ACTD).

The format needed will be determined by the target market and the regulatory authority.

Importance of Accurate Dossier Submission

A properly prepared and precise dossier submission can prevent delays in the process of regulations, the request for additional information, or total refusal. Mistakes, discrepancies, or absent records can have a profound effect on the approval schedule and entry into the market.

Submission of dossiers is a very vital stage in introducing healthcare products to the market. It demands control skills, technical precision, and guidelines strictness. Collaboration with established regulatory service providers such as Masuu Global makes it easy to prepare and submit and approve dossier and gain market access in a short time and in a compliant manner.