Medical Writing & Publishing

Excelya>Capabilities>Medical Writing & Publishing

Excelya’s teams work closely with Pharmaceutical, Biotech, Cosmetic, and Nutritional companies, together with public hospitals to support them in their medical writing activities.

95% of our missions were completed on time.

Customer satisfaction is our priority.

Excelya's scope of action

What we deliver

Medical Writers from Excelya contribute to the writing needs of quality clinical documents including but not limited to regulatory documents and scientific documentation for a wide range of therapeutic fields.

Writing of Regulatory documents:

  • Synopsis, protocols, amendments,
  • Common technical documents (CTDs)
  • Informed consent forms (ICFs)
  • Clinical study reports (CSRs): Phase I to Phase IV
  • Investigator brochure

Writing of Safety documents:

  • Development Safety Update Reports (DSURs)
  • Periodic safety update reports (PSURs)

Writing of Scientific documentation:

  • Abstracts, Posters, Manuscripts, Slide kits

The documents are written in English according to the ICH recommendations and reporting guidelines for health research.

Leading/supporting activities related to writing and review processes of regulatory compliant clinical documents in conjunction with other members of the project team:

  • Responsibility for drafting timelines making sure that they are agreed beforehand and followed up during the process or adjusted as needed
  • Effectively interact with multiple functions throughout the contributions and review processes.
  • Lead document review meetings to ensure that all issues raised are discussed and adequately addressed.
  • Submit CTD documents responsible for harmonization of language across the modules and CSR, taking into consideration the company SOPs.
  • Deliver a critical contribution in presenting data clearly and concisely, but with the appropriate level of detail in order to support the submission process.

Excelya's advantage(s)

The Excelya medical writing team involves more than 20 medical writers with a graduate degree in a scientific discipline or PharmD. They are highly experienced in the pharmaceutical industry and have 10 years on average of experience in medical writing.

Our dedicated team ensures accuracy and compliance with current templates, regulations and international standards as they pertain to achieve deliverables in respect of deadlines.

Our medical writers are flexible, able to work well both remotely or on-site with clinical teams to draft documents, coordinate the review process, and finalize deliverables.

  • Understanding of drug development processes and regulatory strategies,
  • Network with all the functions involved in clinical operations,
  • Compliance with the client’s requirements and standard procedures,
  • Proactivity of Excelya team members in client activities to meet needs and adapt to workload.

Excelya innovates by adhering to a program of excellence and a constant dynamic of ongoing training and certification

Success case

In addition to the writing activities, I was asked to coordinate a project for the preparation of the package for a future regulatory submission in the context of the European Medicines Agency (EMA Policy/0070) guidance related to the publication of clinical data for medicinal products for human use.

This mission was very rewarding and required rapid adaptation with a deep dive into the regulatory environment and therapeutic area of the product