Who We Are
Our medical writing team encompasses dedicated commercial and regulatory writers with > 10 years of industry experience, including a team of editors for quality check of all deliverables. The writers are from multidisciplinary background ranging from PhD holders (in pharmacology, biotechnology, microbiology, genetics etc.) to medical doctors, which provides us an added advantage to deliver documents, with high quality, across multiple therapeutic domains, including oncology, microbiology, cardiovascular, ophthalmology, gastroenterology, musculoskeletal disorders, autoimmune disorders, medical devices, vaccines, metabolic disorders, nutritional disorders, renal disorders, neurology, respiratory disorders and women health. Our team strives to deliver quality deliverables beyond expectation, are highly customer focused with agility and competent enough to meet stringent timelines.
Who We Are
The medical writing team is proficient in preparing regulatory and commercial documents:
- Protocol and its amendments (with summary of changes)
- Informed consent documents
- Clinical study reports
- Investigator brochure’s and its updates
- Integrated safety summaries
- Periodic safety update reports
- Development safety update reports
- eCTD compliant Modules 2 and 5
- Review articles
- Case reports
- Conference abstracts
- Slide decks and posters for scientific conferences
- One page manuscript summaries
The GCE Medical writing team is a group of handpicked medical writers who have qualified experience to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation. Our professionals are already familiar with the therapeutic area and regulatory submission requirements. This shortens time spent on the learning processes and reduces any errors caused by lack of knowledge of the area.
Our team works collaboratively (as required) with different teams on both the client side and inside all GCE departments within regulatory operations, including medical, clinical, biostatistics, clinical data management, and other departments during the process of producing documentation. Our handpicked GCE professionals are also typically dedicated to one client at one time, so they will not lose track of materials, deadlines, and project goals.
GCE’s team also focuses on the continuous enhancement of skills for regulatory, scientific and technical expertise through continuous education and training for regulations and ICH Guidelines.
Refer to the Why GCE? page for more reasons to choose GCE for your project!