Certara Synchrogenix accelerates 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 proven record of success is built on an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.
We share these case studies to demonstrate our commitment to achieving your program's regulatory success.
Case Studies: Assuring Regulatory Success
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提供全天候监管支持，同时提升团队凝聚力
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a technology platform which uses engineered Listeria monocytogenes. The company is headquartered in Monmouth Junction, New Jersey.
通过扩展，支持比原计划大 8 倍的 BLA
A commercial stage biopharmaceutical company focused on the development of novel treatments for B-cell diseases was focused on pursuing FDA approval for a recombinant IgG1 chimeric monoclonal antibody, for the treatment of relapsing forms of multiple sclerosis (MS).
Takeover of lifecycle maintenance of investigational new drug applications
A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy…
Strategic Planning and technology to support a rolling BLA submission under tight timelines
A Tier 3 Sponsor called upon Certara Synchrogenix to support its rolling BLA submission, the second submission we supported for…
为不熟悉流程且缺乏项目经验的申办方新团队提供助力
A commercial-stage biopharmaceutical company recently employed new team members to support the production of patient safety narratives across the primary and extension Clinical…
Certara可以指导公司成功执行透明度与披露活动
In August 2020, an emerging global biotechnology company reached out to Synchrogenix, Certara’s regulatory sciences division, to evaluate the company’s status and strategic…
新兴生物技术公司选择 Certara 作为透明度与披露服务提供商
In early 2020, an emerging global biotechnology company was in need of anonymization and redaction services for upcoming expected Health…
使用技术辅助创作功能，改变有关叙事的叙述
In April 2020, a leading biotechnology company required the authoring of 3,000 narratives in approximately four months across four studies for its BLA.
