Our team of qualified PhD’s and other experts turn complex medical and scientific information into clear and readable documents including:

• Pre-clinical and Clinical Development Plans

• Study design for Pre-clinical Programs

• Investigator’s Brochures

• Pharmacy Manuals

• Phase I - IV Clinical Study Protocols

• Clinical Study Report according to ICH E3 and eCTD format

• Informed Consent Form

• Publications, Abstracts and Posters

• Regulatory Applications and Submissions

• Pre- and Post-approval Aggregate Safety Reports

• Serious Adverse Event Narratives

Whether an integrated part of clinical development expertise or a stand alone service, increase the impact of your medical and scientific program with the help of our experienced team.