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Asphalion

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

Our team has 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.

Medical and Scientific Writing Solutions

We provide specialized expertise in key areas, ensuring a smooth and efficient path to product approval and commercial success:

  • Complete Module elaboration of non Clinical and Clinical sections according to legal basis: Modules 2; 4; and 5.
  • Non Clinical and Clinical Expert signatures of dossiers.
  • ACOs/ANCOs
  • Preparation of RMPs, PSURs and DSURs.
  • Study protocol drafting and Review.
  • IMPD/IND and Investigators Brochure (IB) writing
  • Applications for line extensions to new indications.
  • Responses to agencies and justification of questions
  • Bibliographic searches and compilations to support dossiers and responses to agencies.

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Why Asphalion?

  • Dedicated team with more than 20 years of experience in all types of products and therapeutic areas.
  • Benefit from specialized Medical and Scientific Writing expertise.
  • 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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