IND/CTA/IMD 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. Marketing Application Submission Services 6/23/2015

    Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.

  4. Clinical Product Safety 12/21/2012

    Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.

  5. Pharmacovigilance 6/24/2011

    It's peace of mind -- and more. Global Safety AdvantageSM is an enhanced and seamless Global Safety Surveillance and Pharmacovigilance program.

  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. 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.

  8. 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.

  9. 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.