Regulatory Services

Do your regulatory strategies need sharpening, or do you need additional resources? We offer flexibility and expertise – whether you are looking for someone to help you step up your plans or a full-scale regulatory affairs department, we will deliver!

Use our expertise to ensure correct strategic decisions and a smooth process from product development to market launch.

Correct strategy speeds up the time to market – and benefits patients.

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The regulatory process is often represented as a series of steps which follow one another in a certain order. We regard it as a unified whole, a set of interconnected cause and effect relationships and opportunities for synergy benefits. Phases are completed as planned and on schedule – always taking the fastest route. We identify possible problems in advance and prepare for them, and always have a Plan B in place.

We set a new record for product launches thanks to your efficient management of the regulatory process.

DRA is a trustworthy partner whose quality and expertise you can rely on, even in a crisis.

You can trust our expertise and sleep well at night. Leave it for us to keep abreast of the constantly updated regulatory framework and manage your regulatory issues.

We know the pharmaceuticals industry and recognise its signals.

We will always find the best solution that benefits the client.

Our particular strengths include

  • Strategic, client-oriented approach to regulatory issues throughout the medicinal product’s life-cycle
  • Finding solutions to problems within the limits of guidelines and regulations
  • Coordination of marketing authorisation processes (CP, DCP, MRP and national applications) in Europe
  • Coordination of pan-Nordic labelling projects
  • OTC applications
  • Successful working relationships with authorities and experts in other countries.

Is your knowledge up to date? Order effective training courses from top-level experts.

DRA Academy

We are familiar with the entire life cycle of medicinal products from planning the marketing authorisation strategy and preparing documentation to the application stage, market launch and maintenance.

We can publish electronic submissions in eCTD, NeeS or VNeeS format for submission via CESP and/or national portals. We are also your contact point when it comes to updating your product information texts in Nordic databases (Pharmaca Fennica, Lääkeohje, FASS, Felleskatalogen, DKMAnet).