Regulatory Strategy & Reports

Regulatory Strategy & Reports

A perfectly well planned regulatory strategy is very important to get out of hurdles on non-compliance to regulatory. We at Maven give end to end regulatory strategy for your product to pass in regulatory and market your products with ease. Our esteemed services are not only to US and EU but to the ROW markets as wells.

Market Accessibility

NDA and ANDA Submission:

IND (Investigational New Drug) and IMPD (Investigational Medical Product Document/ Dossier) submission:

IND/IMPD is done for clinical studies. Many number of guidelines have to be followed to get this approval we at Maven has rich experience in providing content for submission on IND /MPD to Regulatory health authority. We update ourselves with the latest guidelines, specific to countries and help clients for submissions

MAA Submission:

Marketing authorization application is required for newly developed hybrid or generic medicinal product in EU and UK.

Submission of NDA/MAA varies with country. To obtain a drug approval a dossier of information with complete process on all aspects like administrative/ Quality/ safety/efficacy of medicine have to be prepared and submitted. A common technical design document consisting of 5 modules need to be prepared.

European market authorization process:

Marketing of generic parenteral product in Europe requires a different regulatory authorization there are four types of procedures to get the marketing approval in Europe.

Centralised Procedure(CP) :

A compulsory procedure for products like Orphan medicinal products, medicinal products for human use which contain active ingredients that are intended for treatment of AIDS, cancer, neurodegenerative disorders or diabetes, products derived from biotechnology, for veterinary medicinal products used for performance enhancers to promote growth or to increase in yields from treated animals. Applications for the centralized procedure are submitted directly to the European Medicines Agency (EMA) and lead to the granting of a European marketing authorization by the Commission which is binding in all Member States.

Decentralized Procedure(DCP):

In a decentralized procedure a manufacturer can apply for simultaneous authorization in more than one EU country that is not authorized in any EU country and that doesn’t fall under centralized procedure.

Mutual Recognition Procedure (MRP):

This is Applicable to the most of conventional medicinal products and is based on the principle of recognition of an already existing national marketing authorization in one or more Member States.

National Procedure (NP):

In order to obtain a national marketing authorisation, an application must be submitted to the competent authority of the Member State.