EXPERIENCE AND ACHIEVEMENTS

Since it was founded in 2009, HEATHICS has contributed to drug development and regulatory strategies for several pharmaceutical companies. Assignments were successfully completed in a variety of therapeutic areas thanks to our experience in the pharmaceutical industry. We dedicate all our efforts to avoid unnecessary review and rewriting by our clients thanks to our high-quality standard in medical writing.

Clinical development strategy
  • Medical and scientific advice on clinical development plans, study design, statistical analysis plans and study results interpretation consistent with expected labelling claims
  • Phase II-III clinical protocols, synopses and clinical study reports in the treatment of cardiovascular diseases including severe haemorrhage and thromboembolism
  • Paediatric Investigational Plans (PIP) in orphan indications
Regulatory support
  • Risk-management plans (RMP), periodic benefit risk evaluation reports (PBRER)/ periodic safety update reports (PSUR) and development safety update report (DSUR) in several therapeutic fields including rheumatology, infectious diseases, cardiovascular diseases
  • Health authorities briefing packages and/or meetings participation for scientific advice on cardiovascular diseases and orphan indications
  • Common technical documents (CTD) modules including summaries and overviews:
    • cardiovascular diseases, urology, rheumatology, infectious diseases;
    • marketing authorisation applications (MAA) and renewals, type II variations;
    • national, decentralised and mutual recognition procedures;
    • stand-alone, hybrid, and bibliographical (well-established use) applications;
    • prescription drugs, over the counter (OTC) products, herbal medicine products and nutraceuticals.
  • Answers to Health Authorities questions
  • Summary of product characteristics (SPC) review and optimisation, company core data sheet (CCDS), company safety information (CCSI)
Market access
  • Anticipate market access requisites for optimal drug positioning and expected therapeutic added value in the design of clinical development programme on cardiovascular diseases
  • “Note d’Intérêt Thérapeutique” for pricing in France: cardiovascular diseases, central nervous system (CNS)
Scientific communication
  • Manuscripts accepted for publication in international peer-review journals on cardiovascular diseases
  • Abstracts, posters and slide set for communication in scientific meetings
  • Review and optimisation of advertising and promotional materials