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Providing Vision and Experience to manage regulatory Submissions in Europe


The European Union represents an important marketing opportunity in terms of dimensions thanks to the existing common regulations among countries via the centralized procedures. The pharmaceutical regulation in this region is governed by supranational bodies, such as the EMA and its working parties and associate partner authorities.

To succeed in the approach to these entities, a correct designation of the product and a detailed strategy about the best way to contact, timings, meeting preparations, obtention of proper advice, management of CTAs, among others, are crucial to achieve an accelerated approval.

Europe Solutions

  • Assessment of specific local requirements for a Member State
  • Assessment of product potential designation according to fast-track possibilities
  • Evaluation of including your product in the Priority Medicines (PRIME) programme for potential accelerated assessment
  • Support in classifying your company as SME (Small Medium Enterprise) and applications of associated waivers and exemptions
  • Regulatory roadmaps, gap analysis and feasibility assessments, including analysis of development time and costs
  • Scientific Advice Meetings (SAs) according to the needs in each stage of development

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Why Asphalion?

With 20+ years track record in handling submissions, Asphalion provides reliable support for all type of regulatory procedures in Europe. We provide regulatory strategy to anticipate any potential hurdle, coordinate your submissions and liaise with European agencies until the approval of the Marketing Authorisation.

Main benefits

Asphalion has large experience in writing, submitting and updating  all types of technical dossiers specified for each product type including:

  • New Chemical Entities
  • APIs
  • Generics and Hybrids
  • OCT market
  • Orphan Drug Designations
  • Biologicals and biosimilars
  • Advanced Therapy Medicinal Products
  • Herbal Medicines
  • Homeopathic Medicinal Products
  • Veterinary Medicinal products
  • Medical devices
  • In-vitro diagnostics and drug-device combinations.
  • Cosmetics and food supplements

Furthermore, Asphalion has a proven track record and experience in following tracks, timings and standard formats in centralized submission procedures involving all intervenient regulatory entities.

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For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

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