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Preclinical development stage

Early assessment of your product to ensure smarter and faster development plan and proper regulatory pathway

Preclinical development stage

Prior to entering clinical trials to confirm in humans the results obtained in preclinical research, a product needs to be correctly defined to ensure the best regulatory strategy and clinical approach. Facilitating a correct definition of the research development and regulatory plan, which involves proper designation of the product, will determine: timings, requirements during later phases, types of meetings to be carried out, the regulatory intermediaries that will be involved, and the possibility of accessing waivers and other mechanisms to accelerate approval that will depend on the medical need to be covered and the nature of the product.

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

Asphalion can be the ideal regulatory partner during these early stages prior to proceeding to clinical research or in the very early stages of clinical research.

Preclinical development stage Solutions

  • Regulatory roadmaps
  • Gap analysis during preclinical development
  • Strategic regulatory and scientific assessment by providing CMC, non-clinical and clinical development plans to bring your product to the patient in the most efficient way
  • Feasibility assessment, including overview of development timelines and costs
  • Strategic search for fast-track regulatory tools: PRIority Medicines (PRIME) programme, accelerated assessment, conditional approval, compassionate use, etc.
  • Company classification as SME (Small Medium Enterprise) and achieving potential waivers associated with the facilitation of research activities

Early phase regulatory meetings:

  • Innovation Task Force (ITF) with EMA, INTERACT meeting with EMA.


Scientific Advice meetings:

  • National Competent Authorities (NCAs) in Europe.
  • EMA: Scientific Advice, Protocol Assistance.


Regulatory Tools

  • Classification of your company as SME (Small Medium Enterprise), with the waivers and advantages this involves.
  • Strategic search for accelerated assessment PRIority MEdicines (PRIME) and accelerated assessment.
  • Regulatory partner for Horizon H2020 projects.
  • Potential waivers definition.


Orphan Drugs Designation (ODD)

  • Management of Orphan Drug Designation (ODD) procedures, including pre-submission.
  • Preparation of Orphan Drug Designation (ODD) applications, including significant benefit, prevalence calculation and medical plausibility.
  • Experience with both EMA and FDA.
  • Orphan designation for UK market.


Paediatric Investigational Plan (PIP)

  • Regulatory strategy, preparation and submission management of Paediatric Investigational Plan (PIP) for EU and Pediatric Study Plan (PSP) for US
  • UK PIPs.


Support in Clinical Trial Application in EU (preparation and submission), UK and US.

  • Clinical Trial Application (CTA), also those based on the new CTIS Regulation in EU.
  • IMPD (Investigational Medicinal Product Dossier) and IB (Investigator’s Brochure) generation and update.
  • Investigational New Drug applications (IND) preparation and submission in US.
  • Clinical Trial Application in UK.


Advanced Therapy Medicinal Products (ATMP) Specific Services:

  • CMC consultancy
  • Pre-clinical regulatory advice
  • GMO submissions
  • ATMP classification and certification
  • Long-term project management and consulting with investigator groups and biotech companies.
  • ATMP and Biologic Product Expertise: Oncolytic viruses, adeno-associated virus (AAV), modified vaccinia virus (MVA), plasmids, lentivirus, adenovirus (AdV), Car-T Mesenchymal stem cells, bone marrow-derived hematopoietic stem cells, adipose-derived stem cells, aptamers, antibodies, biologics, vaccines, personalized medicine, tissue engineering products, dendritic cells (DCs).

Call management, presentation and project execution.


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Why Asphalion?

Asphalion’s team has an extensive academic research experience and broad scientific background in the area of non-clinical and CMC writing for Innovative, Biological, Biotechnological, and Advanced Therapy Medicinal Products. The experience of Asphalion’s team allows the selection of the best regulatory strategy for early developments.

Asphalion has been supporting early development projects for more than 20 years, providing regulatory advice and regulatory strategy for the development and further commercialization of innovative medicinal products and medical devices, helping to minimize the times and maximize the cost efficiency.

Also, we have worked in 15 successful PIPs and 20 ODDs. Our regulatory strategy experts have participated in scientific advices with EMA, as well as National Competent Authorities, such as: PEI, AEMPS, DKMA, CbG, MPA, among others.

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