Dedicated team of global regulatory experts drives the approval of rare disease treatments
RADNOR, Pa. — 2024 年 10 月 1 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in model-informed drug development (MIDD), today announced it has successfully supported 100 rare disease drug submissions to regulatory agencies worldwide. Submissions include Investigational New Drug (IND), initial Clinical Trial Applications (CTA), and New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA).
Certara has supported clients’ global regulatory submissions across a range of therapeutic areas and drug types. Their dedicated Rare Disease Center of Excellence helps clients define the clinical relevance of an investigational drug for the intended patient population.
“Drug development for rare diseases presents unique clinical and regulatory challenges. They affect smaller patient populations. So, recruiting for trials is difficult. Measuring and assessing improvements in participating patients is even more difficult,” said Steve Sibley, Vice President, Global Submissions and Submission Leadership.
“Patients living with rare diseases often have unmet medical needs. Our regulatory writing, regulatory strategy, and submission experts have been helping our clients address these needs for many years,” said Patrick Smith, President, Certara Drug Development Solutions.
Certara’s specialist drug development and submission team has supported rare disease submissions to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, and health authorities in 8 other countries. Their regulatory team consists of more than 200 consultants, writers with proficiency in CMC, Nonclinical, Clinical, Regulatory Submission and Strategy, Document Quality, and Regulatory Operations/ electronic common technical document (eCTD) Publishing, as well as Clinical Pharmacology, Pharmacometrics, and Mechanistic Modeling Consulting. These experts understand how to articulate the results derived from both virtual (i.e., using modeling and simulation) and clinical studies.
In addition to regulatory submission services, Certara offers a software portfolio that saves clients time and resources in submission development.
The software portfolio includes:
- Pinnacle 21TM software is used to facilitate all aspects of preparing clinical trial data for regulatory submissions.
- CoAuthorTM, an advanced Life Science Specialized GenAI regulatory writing platform designed for medical writers.
- GlobalSubmit TM eCTD submissions management software.
To learn more about best practices for simultaneous submissions to the FDA and EMA, watch this webinar.
关于 Certara
Certara 致力于通过生物模拟软件、技术和服务加速药物研发，改变传统的药物研发方式。其客户包括超 2,400 家生物制药公司、学术机构和来自 66 个国家的监管机构。Learn more at www.certara.com.
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