Regulatory Affairs Outsourcing

It suits companies with a human medicinal product portfolio in Türkiye that do not want to, or have not yet, set up their own regulatory affairs department. Companies that already have an RA department can also use it to support their team during busy periods or for specific procedures.

Your company does. Melvin does not act as MAH; we work as your external regulatory affairs department. Under the Regulation on the Marketing Authorisation of Human Medicinal Products, the MAH is responsible for the compliance of its applications, the undertakings it gives to TİTCK and the accuracy of the documents it submits. That responsibility stays with your company; we take on the preparation and follow-up of the procedures.

MA applications and follow-up, variation, renewal and MA transfer applications, correspondence with TİTCK, the portfolio calendar and regulatory monitoring, as well as price applications, periodic price change applications and SGK reimbursement procedures. Services such as PIL readability testing, ePIL conversion and translation can be planned separately when needed.

The scope is agreed together, based on the number of products in your portfolio, the applications planned in the near term and your pricing and reimbursement calendar. We start by mapping the regulatory and pricing status of your portfolio and bringing all deadlines into a single calendar.

We identify the products that need to apply in each price change period, prepare the application files and submit them on schedule. Because the same team follows regulatory changes, their impact on price applications is tracked without gaps between the two processes.