Dossier preparation for ROW & Semi Regulated markets.
- Preparation and compiling the dossier based on quality, safety & efficacy information.
- Helping in assisting response required to submit HA.
Post approval submission packages.
- Assisting in preparation of variation package.
Post CMC compliance
- Assisting in identifying gaps in MAH submission documents & current documents.
Preparation of SPC & Package Insert.
- Patient information leaflet
Clinical and Non clinical document support.
- Clinical literature & non clinical literature review and compilation.
Regulatory Affairs
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.