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.
Our highly qualified team of writers include PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory). 製薬業界において最高水準を誇る SOP によって優れた文書品質を保証します。専任の品質管理チームとライティングチームの効果的な連携を通して作成される文書は、レビューのプロセスを最短化し、承認申請完了までの期間を短縮します。
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.
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.