Regulatory Strategy and Scientific Advice during Development

The Regulatory Strategy Is the Best Pathway to Draw Up Suitable Clinical Development Plans.

The experience of Asphalion’s clinical development team allows the selection of best regulatory strategy from all existing possibilities.

Strategic inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimum time-to-market, and others.

Regulatory Strategy Roadmaps

Non-clinical and clinical development plans, including assessment of feasibility, strategy, timelines and costs

Scientific Advice EMA, EU-NCAs and FDA

Regulatory strategy expertise for optimal outcome with EMA, EU-NCAs, FDA and other agencies

• Paediatric Investigation Plan (PIP)
• Orphan Drug Designation (ODD)
• Clinical Trial Application (CTA)
• Investigational Medicinal Product Dossier (IMPD)
• Investigator’s Brochure (IB)
• Regulatory Partner for Horizon 2020 Programme

Why Choose Asphalion to Handle your Regulatory Strategy and Clinical Development Plans?

Asphalion has already worked in 15 successful PIPs and 20 ODDs, along with Parallel FDA and EU submission for Fast Track / Conditional Approval. Our regulatory strategy experts have participated in Scientific advice with EMA as well as National Competent Authorities such as, PEI, AEMPS, DKMA, CbG, MPA, among others. We have been involved in the UAT of EMA for the new CT portal, and worked with EudraCT  and clinicaltrials.gov.

Besides, Asphalion has already been involved in 10 EU H2020 funded projects: iHIVARNA, MYOCURE, ELASTISLET, iHIVACAR, nTRACK, CardioReGenix, SBR , MISTRAL, VASCOVID and ARDAT.