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.
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:
Writing of Safety documents:
Writing of Scientific documentation:
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:
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.
Excelya innovates by adhering to a program of excellence and a constant dynamic of ongoing training and certification
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