Regulatory Affairs

It is our goal for your products to achieve approval as quickly and cost-effectively as possible. We provide comprehensive regulatory and Pharmaceutical support for companies in Europe for:

  • Human medicinal products
  • Veterinary medicinal products
  • Herbal medicinal products

Whether you’re looking for dossier compilation and registration or later life cycle management activities, Axano Pharmaceutical will work with your team to bring professionalism as well as an understanding of the implications for costs and time.

Our specialisations include

  • Medicinal products based on established API’s (e.g., small molecules or peptides) for generic
  • OTC and value-added medicines
  • Mixed applications
  • New fixed dose combinations
  • Herbal and veterinary medicinal products

Our Drug Substance Services Include

  • Development and preparation of ASMF/EDMF and US-DMF
  • CEP applications
  • Life cycle management including: variations, revisions, renewals

Our Drug Product Services Include

  • Product development and regulatory due diligence
  • Regulatory strategies
  • Pre-submission
  • Scientific advice procedures at regulatory authorities
  • Dossier evaluation and gap analyses
  • Writing chemical-pharmaceutical documentation
  • Writing and review of clinical (CO) and non-clinical overviews (NCO)
  • Compiling pharmacological-toxicological and clinical documentation
  • Writing pharmaceutical-chemical expert reports
  • Preparation, submission and management of Marketing Authorization Applications national, centralized (CP), decentralized (DCP) and mutual recognition procedures (MRP)
  • Preparation of product information (PI) SmPC, patient information, labelling
  • eCTD in-house publishing

We’re passionate about the work we do, which is why we always ensure we keep ahead of the game with all aspects of regulatory and statutory requirements all over Europe. Our team is dedicated to supporting small, medium and larger pharmaceutical companies find cost and time-effective solutions to their regulatory needs.

Related Services

Intellectual Property Services
Regulatory Affairs
Reference products sourcing


  • Unlimited access to technologies and processes at any scale through our large network of cooperation partners worldwide: we are not limited to certain technologies or batch sizes and do not have to fully utilize own production capacities.
  • Through a proven track record of established partnerships in development and production, we enable invaluable synergies for the benefit of our customers.
  • Reliable analysis & evaluation of the market potential of development ideas through our international expertise & know-how along the entire pharmaceutical value chain.
  • Detailed knowledge of country-specific requirements through our local Midas-offices in all regulated markets.
  • Dedicated & flexible project management which ensures efficient, transparent and fast project execution fitted & adaptable to your individual needs.
Box Van Trailer

Business Development & Licensing Support

Since our founding, Axano Pharmaceutical has been sourcing and supplying of substances ensuring complete compliance with the corresponding industry requirements and uses. Thanks to our extensive experience, we can ensure you’re compliant no matter your industry or where you’re based.

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