Expanding our global footprint

Insight Medical Writing has been acquired by Certara, the global leader in biosimulation, as of June, 2021.

“Joining Certara is a natural next step in our journey. We share common values and a commitment to quality,” said Kerry Walker, founder of Insight Medical Writing. “This is a complementary fit in terms of culture, clients and technology. We are excited about joining the Certara family and the opportunities it will bring, in particular allowing us to expand our services to our clients.”

The global regulatory landscape is complex and evolving. Biopharmaceutical sponsors need to rely on partners that can support sequential, parallel, or even simultaneous submissions to multiple global regulatory agencies. Certara accelerates these steps in the drug development process through its regulatory talent and technology.

Insight’s talented team of medical writers and services experts join Certara’s regulatory experts in assuring and accelerating the approval of and access to medical innovations through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, transparency and disclosure, and operations solutions.

Medical Writing to expedite your submissions

监管写作以加快您的提交我们的高素质作家团队包括拥有所有职能领域(文件质量、CMC、非临床、临床和监管)背景的博士、医学博士、药学博士、科学家和护士。业界一流的 SOP 可以提高质量,而专门的质量控制职能部门和一体化的写作团队则可以减少审稿人的评论并缩短完成时间。

As key opinion leaders, Certara’s medical and regulatory writers speak regularly at major industry events such as DIA Annual, DIA Europe, AMWA’s Medical Writing and Communication Conference, and EMWA.

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Assure patient safety with integrated expertise

Confidently achieve safety-related document compliance with a seamless integrated team powered by technology. Certara’s safety and pharmacovigilance experts deliver project management, data analysis, medical writing, and medical review capabilities around-the-clock.

Our team supports safety-related document authoring throughout the entire safety lifecycle for major global agencies. This includes patient safety narratives, eCTD documents (2.7.4, ISS), aggregate reports, risk management plans, cumulative safety analysis, literature searches, global value dossiers, and signal evaluations.

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