Biologicals

Our expertise with Biologics helps you succeed in the complex development and registration of this type of product

Biologicals

Asphalion’s teams have both academic research experience and a broad regulatory and technical background in the development and registration of Biologics, including all types of Advanced Therapy Medicinal Products (ATMPs). Our expertise allows us to select the best possible regulatory strategy for your Biological product.

Asphalion can elaborate all regulatory, non-clinical, clinical and CMC documentation required during development, registration and life cycle of Biologics. In addition to this, 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, among others.

Asphalion’s teams have both academic research experience and a broad regulatory and technical background in the development and registration of Biologics, including all types of Advanced Therapy Medicinal Products (ATMPs). Our expertise allows us to select the best possible regulatory strategy for your Biological product.

Asphalion can elaborate all regulatory, non-clinical, clinical and CMC documentation required during development, registration and life cycle of Biologics. In addition to this, 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, among others.

Our Solutions

Ad hoc regulatory advice and strategic consultancy:

  • 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
  • Preparation of briefing packages and attendance to the meetings with authorities
  • National Competent Authorities (NCAs) in Europe
  • EMA: Scientific Advice, Protocol Assistance, Innovation Task Force (ITF)
  • FDA: INTERACT, Pre- BLA/NDA, PRE-IND, EOP2
  • Management of ODD procedure including pre-submission
  • Preparation of ODD applications including significant benefit, prevalence calculation and medical plausibility
  • Experience with both EMA and FDA
  • Regulatory strategy, preparation and submission management of the PIP for EU and the Pediatric Study Plan (PSP) for US
  • Preparation of Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB)
  • Clinical Trial Application (CTA) submission in EU
  • Ad hoc support during Clinical Trial conduction
  • IND Preparation and Submission
  • Preparation of complete dossiers ready for registration procedures, including expert’s signature
  • Gap analysis and update of CMC, non-clinical and clinical sections
  • Technical documentation: scientific reports, PSURS, ACOs, etc.

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Why Asphalion?

Thanks to our extensive experience working with Biological products and Biosimilars, we are the ideal partner for defining the best regulatory strategy for our clients´ Biological products.

As part of our modular and flexible support model, we can either assist you with gap analyses of existing documentation or take on the preparation of entire registration dossiers.

We can advise on critical interactions with authorities, such as scientific advice procedures, and can manage them completely for our clients.

Difficult topics, like the extrapolation of indications, are assessed and managed by our senior experts.

We have successfully written full biosimilar dossiers, including all CMC parts, non-clinical and clinical sections, have prepared and attended pre-submission meetings with EMA, and have supported the management of Centralised Procedures and Biologics License Applications, including elaboration of responses to authorities.

For further information

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