Medical and Scientific Writing

Our Medical and Scientific Writing team provides you with support to build the foundations of strong non-clinical and clinical developments

Medical and Scientific Writing

Asphalion’s 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.

Asphalion’s 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.

Our Solutions

Ad hoc regulatory advice and strategic consultancy during product 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 timelines development and costs
  • Preparation and submission of briefing packages and attendance to meetings with the 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 Orphan Drug Designation (ODD) procedure, including pre-submission
  • Preparation of Orphan Drug Designation (ODD) applications, including significant benefit, prevalence calculation and medical plausibility
  • Experience with both EMA and FDA
  • Regulatory strategy, preparation and submission management of Paediatric Investigational Plan (PIP) for EU and Pediatric Study Plan (PSP) for US
  • Classification of your company as SME (Small Medium Enterprise)
  • Priority Medicines (PRIME) and accelerated assessment
  • Conditional approval
  • Hospital exemption
  • 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, ERAs, PSURS, ACOs, etc.

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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 specialized Medical and Scientific Writing expertise.
  • Get support to meet tight schedules.
  • Anticipate and overcome potential barriers.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

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