GlobalSubmit™ Submissions Management Software and Services

GlobalSubmit Submissions Management Software and Services

Facilitating Regulatory Submissions Due to the enormous amount of information in a drug marketing application, regulatory agencies require sponsors to submit applications electronically in formats that facilitate their review, such as the Electronic Common Technical Document (eCTD). To comply to the complexities and requirements of electronic submissions, regulatory teams need to complement their expert staff […]

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Regulatory Strategy

Achieving Regulatory Milestones Having a well-constructed regulatory submission strategy that is interwoven into a sponsor’s operational program is even more critical to achieving success than in the past. Between the escalating competition, speed, cost, and risk; benefit pressures on sponsors; the need for payers to see ‘best-in-value’ data of a drug to justify adding it […]

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Artificial Intelligence Software

Empowering Regulatory Sciences Artificial Intelligence (AI) technology is revolutionizing life sciences, and over the next decade, will continue to enable advancements at unprecedented rates. Through the use of AI technology, Synchrogenix has developed a solution in the area of regulatory and medical writing that truly meets the promise of automated authoring and is also the […]

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Transparency and Disclosure

Mitigating Risk and Ensuring Compliance As the issue of transparency and disclosure (T&D) of clinical trial information has grown in importance, so has the recognition that sharing clinical trial information is a key step toward increasing trust between the public and the industry. More importantly, increased transparency regarding data about ongoing research could spur new […]

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Strategic Regulatory and Medical Writing

Strategic Writing Leadership is Key to Successful Drug Development There is tremendous complexity and variability in any drug development program. It takes leadership and strategy to develop one story and a plan that considers all variables and contingencies. Sponsors need a trusted, agile, and experienced partner not only to prepare these documents, but also to […]

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Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

There is a renewed surge of interest in applications of physiologically-based pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies. Developing PBPK models within a systems pharmacology context allows separation of the parameters pertaining to the animal or human body (the system) from that of the drug and the study design which is essential to develop […]

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About Our Consulting Services

Your Partner for Optimizing Drug Development Committed to scientific, regulatory and commercial advancement, Certara has organized its capabilities to create impactful patient-focused solutions. The largest and most comprehensive provider of strategic drug development, modeling and simulation and regulatory science services, Certara is your partner for optimizing drug development decisions. We are dedicated to helping our […]

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