NDA/BLA/MAA Services & Products

1. Medical & Regulatory Affairs 3/4/2016

   Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

2. Medical Writing 3/4/2016

   As an international, full-service clinical contract research organization, SynteractHCR strives to deliver actionable results for your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies. Our medical writers are committed to delivering a well-designed clinical program that will meet your study’s ultimate goals.

3. Adverse Event Management 12/21/2012

   At Sentrx, we run the gamut, covering every aspect of pharmacovigilance for all stages of development and all sizes of clients. Whether your circumstances are more heavily influenced by clinical needs or post-marketing surveillance requirements or you are examining drug safety as part of your New Drug Application planning or preparing to implement risk mitigation strategies, Sentrx has the expertise to make your drug safety operations more flexible, cost-effective, and efficient.

4. DESI (Drug Efficacy Study Implementation) Drugs Approval 8/8/2011
   Camargo will work with you to prepare a comprehensive plan to secure approval for DESI (Drug Efficacy Study Implementation) drugs.
5. 505(b)(2): Is it for you? 8/5/2011
   A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant.
6. Regulatory Affairs 6/24/2011

   Our team of Regulatory Affairs experts plays a pivotal role in your project from initiation to completion, ensuring compliance with applicable laws and regulations throughout the process.

7. Clinical Writing 6/24/2011
   Our experienced Clinical Writing professionals are committed to working with you—in accordance with US/EU/ICH guidelines and regulations—to deliver a wide range of high-quality clinical materials on time and in your style/format.
8. Marketing Applications

   Setting the highest standards for marketing applications
   A marketing application is the most critical milestone in your clinical research program. Quality applications can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life – demanding a partner with an insider’s understanding of the regulatory landscape and a proven track record for success.

9. Consulting

   Clinical trials involve a myriad of complicated processes and variables. Rho can help you navigate the clinical trial process to save you time and minimize costs.

10. Medical Writing

    Writers with both industry and therapeutic expertise
    Each member of our core regulatory and medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements and provide top notch medical writing services. Each writer is a graduate-level life science scholar. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. Their experience and training enable them to expertly prepare reports in accordance with regional regulations and ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to regulatory authorities, including FDA and EMA.