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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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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