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Local Regulatory Affairs Support in Central Eastern Europe

Insource our Local Regulatory experts.

When and where you need them the most.

Product lifecycle management is a challenge for Marketing Authorization Holders in a highly competitive market and a context of constant scientific and technological advancement. To help you deal with the regulatory and administrative obligations we have a dedicated team to manage these activities efficiently and effectively. Get in touch to see how we can extend your reach with Local Regulatory Affairs Support in Central Eastern Europe.

A complete and well-developed regulatory strategy ensures long-term continued success for your product. In addition to keeping your product on the market, a strategic approach can maximize its potential through efficiency, but also possible line extensions or additional indications. Acting as a seamless extension of your team, we work with you to set up efficient product lifecycle management strategies and offer years of experience and a hands-on approach covering throughout Central- Eastern Europe.

Finding the right balance.

Between compelling and compliant.

On-Market compliance without a care.

As medicinal products that are already marketed change over time, expertise in renewals, variations, and other medicinal product lifecycle management activities is one of the key elements to reach your company’s business goals.

Our services range from clinical development, marketing authorization and post-authorization activities. Our experienced regulatory affairs team provides medicinal product lifecycle management services to our clients and offers solutions according to the scope and extent of your project. Our Local Regulatory Affairs Support in Central Eastern Europe also includes representation and acting on behalf of our clients with Health Authorities.

Biomapas full-scope product lifecycle management services include:

  • Marketing authorization renewal management;
  • Variation management (type IA, IB, II);
  • MAH transfer;
  • eCTD compilation and publishing;
  • Labelling support;
  • Non-EU dossier changes / modifications / amendments;
  • Product line extensions;
  • Product status change (Rx/OTC);
  • Sunset Clause management;
  • Advertising and promotional material review;
  • Notifications to authorities;
  • Post-Authorization Commitments.