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Drug Development Consulting

Our Regulatory and Strategic Consulting team offers comprehensive support throughout the drug development process, from initial stages to market launch.

Drug Development Consulting

Asphalion’s Regulatory and Strategic Consulting team offers comprehensive support throughout the drug development process, from initial stages to market launch.

Our team has academic research experience and a broad scientific background in non-clinical, clinical and CMC writing for different types of products, including innovative, biological, biotechnological and advanced therapies medicinal products. Asphalion’s expertise allows us to offer the best regulatory strategy for each project.

We can support you with all sort of regulatory related documentation required during the clinical development and registration. In addition to this, strategic inputs can be provided from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimal time-to-market, among others.

Drug Development Consulting Solutions

We provide expert guidance and solutions in all the required areas, ensuring a seamless journey towards successful product:

  • Ad hoc regulatory advice and strategic consultancy during product development
  • Regulatory Roadmaps and preparation of preclinical and clinical development plans
  • Feasibility assessment, including overview of timelines development and costs
  • Scientific Advice meetings preparation with regulatory agencies (EMA, FDA, MHRA and NCA)
  • Support in Clinical Trial Application (preparation and submission) in EU (IMPD via CTIS) and US (IND)
  • Assistance in the preparation of Orphan Drugs Designation (ODD) and Pediatric Investigational Plans (PIPs) in EU and US
  • Fast track Regulatory Tools (PRIME, Conditional Approval, ILAP, Breakthrough program, etc)
  • Experts in EU and FDA procedures and strong expertise with ATMPS, Biologicals and Biosimilars

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Why Asphalion?

  • Dedicated team with more than 20 years of experience in all types of products and therapeutic areas.
  • Strong expertise with innovative NCEs, ATMPs, Biologicals, vaccines and Biosimilars.
  • Benefit from our expertise from lab to market
  • Get support to meet tight schedules.
  • Anticipate and overcome potential barriers.
Nuria Coderch - Asphalion
Núria Coderch
Scientific and Regulatory Affairs Director
“We are a dedicated team with more than 20 years of experience in all types of products and therapeutic areas. We have strong regulatory expertise in drug development with innovative NCEs, ATMPs, Biologicals, Vaccines and Biosimilars”

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