Regulatory intelligence for pharmaceuticals

Rely on DRA’s regulatory intelligence teams to help you understand and stay up-to-date with the market and regulatory environment. We will provide the information, analysis, and solutions that Marketing Authorisation Holders need to decide on product development, regulatory processes and launch strategies.

Our Regulatory Intelligence services for pharmaceuticals include:

  • Regulatory and market entry strategies
  • Writing, compiling and submitting marketing authorisation applications
  • Regulatory processes (CP, DCP, MRPand NP)
  • Regulatory maintenance (variations, renewals, extensions)
  • Full European coverage

Let DRA guide you through the regulatory process from start to finish, all the way to the successful launch of your pharmaceutical product. We can provide the information, analysis, and solutions you need to decide on the optimum strategy to obtain market authorisation and maintain the licenses for your pharmaceutical product.

Whether you want to sharpen up your strategy and develop your plans, or you need the support of a full-scale regulatory affairs department, we have the flexibility and the capability to help you out. Our professionals continuously stay up-to-date with developments in the medical industry and changes in the regulatory environment, so they always have the latest knowledge available.

As part of our service, we can compile applications, instruct customers on the documentation needed for their chosen application procedure, write documents and also submit applications to the relevant authorities. We will also support you in updating your product information texts in the Nordic databases.

Let DRA handle due diligence and gap analysis for your pharmaceutical products. Our specialists will take care of all necessary procedures, thoroughly checking and updating all the required documentation to ensure you can maintain marketing authorisation.