Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Amsterdam, Munich and London.

Asphalion provides a global range of services, for global clients.

We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.

Since 2000, we have consistently grown and now have almost 100 professional consultants with backgrounds in Life sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine).

Our consultants are experts in their field and are in direct contact with EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards.

Our services range from early development, throughout the registration, until marketing and post-commercialization phases of your product.

Through our network of regulatory consultants, Asphalion is in a position to support your worldwide scientific & regulatory activities. We make use of a dedicated US agent in the fields of Pharma/Biotech, Medical Devices and In Vitro Diagnostics.


  • Area of Activity
  • Legal services
  • Animal health
  • Chemistry
  • Pharmacy
  • Drug development
  • Medical Devices
  • Consultancy
  • Company type
  • Services and consulting for biotech sector
  • Agrifood Biotechnology - Vererinary - Environmental
  • Industrial Biotechnology - Manufacturers
  • Health Biotechnology
Office
C/ Tarragona 151-157, Planta 10, Bloque A
Barcelona, Barcelona 08014, ES
P: +34 93 238 5945
F:+34 93 238 5946
E:info@asphalion.com
Office
St.-Martin-Str. 53-55, of. 401
München, München D-81669, DE
P: +49 (0)89 921 314 230
E:munich@asphalion.com
  • David Mauleón, PhD. General Manager
  • Lidia Cánovas. General Manager, Regulatory Affairs
  • Núria Romero. General Manager, Operations
  • Consol Bozzo, PhD. EU QPPV. Regulatory Affairs Director
  • Núria Coderch, PhD. Scientific Regulatory Affairs Director. Drug Safety Director
  • Michael Schaub. Director Munich Office
  • Carmen Ulla. Quality Assurance Director. Regulatory Affairs Director
  • Ricard Sagués Antona, Business Development & Marketing Director
  • Vicente Tur, Regulatory Affairs Director

Regulatory Support during Development

  • Feasibility assessments by our team of experts
  • Roadmaps: Non-clinical and clinical development plans, including timelines and cost forecasts
  • Scientific advice: Expertise for optimal outcome with EMA, EU-NCAs, FDA
  • Orphan drug designations: minimum time and effort for EMA and FDA

Writing and Authoring

  • Complete and compliant CTD registration dossiers for all types of products
  • Gap analysis and update of clinical, non-clinical and quality documentation
  • Technical documentation: IMPD, IB, CTA, SA briefing packages, ODD dossiers and more

eSubmission

  • Comprehensive eCTD services: latest tools used by experienced e-regulatory specialists
  • Ad-hoc assistance for eCTD compilation projects with your choice of technology
  • Lifecycle support for guaranteed compliance
  • Technology assessment for e-standards implementation projects

Training

  • Regulatory Affairs seminars for experts or beginners
  • Technology workshops for e-Regulatory Affairs
  • In-house training

Regulatory Strategy

  • EU procedures (CP, DCP, MRP, NP): minimum time-to-market and maximum cost efficiency
  • Experts in DCP strategy
  • Global roll-outs including emerging markets and direct FDA insight via US agent
  • Medical device classification strategy

Submission Management

  • Experience and confidence for all types of EU MA submission projects
  • Reliable coordination of FDA and ROW submissions
  • Dedicated project management to comply with critical timelines

Optimized Product Maintenance

  • Maximum efficiency for Variations, Renewals and Notifications
  • for all types of EU/ROW products
  • Drug Safety services, including preparation of PSURs and Clinical Expert statements
  • Pharmacovigilance and local representative

Our name ASPHALION derives from the Greek word aspháleia, alluding to values such as firmness, stability, certainty, and reliability. This is how we would like to be seen by our clients: a reliable partner providing firm and consistent solutions.

Pharma, Biotech and Medical Devices companies

Asphalion