Medical Writing Regulatory Affairs

Medical Writing

Our Medical Writing

The Medical Affairs Unit is a team of experienced people with on average 25 years of experience and professionally qualified with pharmaceutical & medical degrees (MDs, PhDs).

Medical writers have strong scientific knowledge in most major therapeutic areas:
(Dermatology, Oncology, Transplant, Cardiovascular, Immune system, Neurology disorders, AIDs, Digestive, Pain, ATMP, Biosimilars, Biologics, Herbal Products and Homeopathic Products) and possess a deep understanding of applicable regulations/guidelines to work in close collaboration with Sponsors, Regulatory Affairs Personnel, Medical Units, Methodologists and Operational Teams internationally.

We provide the following services:

  • Full Dossier for MAA (Medicinal Products for Human Use & Veterinary Use, OTCs, Generics, Nutraceuticals, Medical Devices, Cosmetics, Products for self-care, Biocides, Biologicals (including ATMP, Biosimilar products) authorization processes.
  • Packaging Material
  • Product Labelling
  • ERA
  • PV System
  • Risk Management Plan
  • Clinical Study Report
  • IMPD
  • IB
  • CRF
  • Protocol and synopsis
  • Informed consent forms, letter to GP, patient cards, and other patient material
  • Preparation/adaptation of clinical documentation in local language
  • Manuscripts and Scientific Publications
  • Posters and abstracts
  • Promotional and Educational Material
  • Systematic Literature Reviews

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