Product registrations

Missionpharma has a team of registration specialists taking care of all product registration activities worldwide.

The Registration department is an integrated part of Missionpharma’s QA/QC department and operates as a co-ordinating unit between Missionpharma's sales people, the manufacturers and the local health authorities.

Activities

The overall activities of the Registration department is to obtain and maintain marketing authorisations for our generic products in the developing world. It is our duty to optimise the registration process to ensure that the time-to-market period for all products is reduced in every possible way.

A team of professional registration specialists carries out the co-ordination work of collecting documentation and relevant WHO certificates, preparing files, translating documents to other languages etc. in order to meet the individual requirements of each receiving country.

In the year 2006, we obtained more that 400 product registrations worldwide, and we continue our efforts to add new registrations to the list.

Product dossiers All product dossiers are strictly evaluated according to WHO guidelines by assigned members of our QA/QC department.   As per customer requirements, we collect the requested documentation covering technical dossiers, stability

Registrations challenges

Missionpharma holds several hundred product registrations in more than 25 developing countries and applications for new product registrations are continuously in the pipeline.

Registration authorisations are issued for a specified time only (typically from one-five years) and requires renewal before expiry. Therefore a very important part of our registration activities is to maintain and update the existing authorisations and handle eventual variations (e.g. changes in product compositions, changes in the production methods or in method of analysis), which often require new documentation. 

 Read more about how we have outsourced part of our product registration activities to our subsidiary office in India.