Therapeutic Areas of Expertise: Strategic Drug Development Services
Certara’s global consulting team has unparalleled experience across all development phases and in all major therapeutic areas. We have collaborated with sponsors, both large and small, to provide insight into key decisions, including dosing and toxicity, efficacy and biological impact, comparative effectiveness, clinical trial design, regulatory strategy, and regulatory submittal. Within each discipline, we help biopharma companies address questions such as what programs should be advanced in a strategic drug portfolio, how trials can be designed to achieve technical and regulatory success, what the optimal dose and regimen is, and how the regulatory burden and risk can be minimized.
With the largest and most diverse team of its kind, Certara’s scientists and regulatory specialists have worked in virtually all TAs, including novel therapies and combination products, across the full range of regulatory pathways. Examples are as follows:
- Central Nervous System
- Infectious Disease
- Orphan Drugs
Therapeutic areas include: