Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Blog Post
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory...
Best Practices for a Successful eCTD Submission Blog Post
Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best practices for addressing them.
How to Perform Level C IVIVC in Phoenix On-Demand Webinar
Step-by-step guidance for Level C IVIVC studies.
Clinical Pharmacology—The Quarterback of Drug Development Press Coverage
Clinical pharmacology accounts for about 50% of a drug label. Its scope ranges from facilitating the discovery of new target molecules to determining the effects of drugs in different populations. From both industry-wide and regulatory perspectives, the levers of clinical pharmacology can address the huge challenges of late-stage attrition and increase the efficiency of drug development in the quest to bring the "ball" into the end zone.
Investigational Drug Gap Analysis Brochure
As the process of drug development has increased in cost and complexity, Certara has developed a service offering to assess a sponsors' development program across multiple domains, and to craft a strategy to address each.
Drug Asset Evaluation: Increasing “Probability of Success” of a Deal White Paper
Certara's due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise on acquiring or investing in emerging biopharma companies.
