:: Medreich ::

RXL - Regulatory Excellence Centre

RXL is an independent knowledge based corporate entity handling the regulatory documentation for the entire Medreich Group.
RXL has a team of experienced regulatory professionals from various disciplines like Pharmacy, Pharmacokinetics, Chemistry, Analytical Chemistry, Bio-analytical Chemistry and Microbiology in equimolar ratio.
Regulatory Team is competent in preparing CMC, pre-clinical, clinical, Product Information (SPCs/Package Inserts (PIs), Labeling, and Patient Information Leaflets (PILs)) through Regulatory Strategic Planning, Management and compliance.
RXL is comprised of several dedicated teams having knowledge of all aspects of the product and its registration in various markets such as Europe, Asia, Australia, New Zealand, South Africa, French West Africa, Rest of Africa, GCC, Canada and USA.
Regulatory Team also handles the regulatory requirements of Strategic Alliance partners who have outsourced manufacturing to Medreich.
Regulatory Excellence Centre has successfully filed several dossiers in European Union and received Marketing Authorizations for Medreich and several more are under approval stage.
There is also a pipeline of new products planned in R and D (Genovo), which are presold to marketing partners in Europe. Projects undertaken, include Sunset clause dossier updation for Europe, and dossier compilation for Genovo.
Regulatory Excellence Centre is ready for eCTD submission in EU and US.