Asphalion - Biotech Spain

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

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