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.
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.
Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.
In July 2012, a series of pharmaceutical legislation became effective in the European Union (EU), which included new requirements for Marketing Authorization Holders (MAH).
An effective quality system is critical to compliant research and thus regulatory approvals.
Whether you're looking to resource a single audit, develop or manage an entire audit program, or bring in an interim quality assurance manager to support your team, Halloran provides experienced, cost-competitive, and responsive quality and compliance services for Good Clincal Practice (GCP) and Good Laboratory Practice (GLP).
At INC Research/inVentiv Health the Quality Assurance (QA) team interacts directly with clients to understand the specific requirements for their product development project.
Ropack Pharma Solutions offers turnkey primary and secondary pharmaceutical packaging services of solid oral dosages into blisters, bottles, flip-top vials, stick-packs and sachets.
Remember the time when laboratory kits were ordered and reordered by sites faxing in pieces of paper, and laboratory reports were faxed and express mailed to investigative sites around the world? Sadly that time is still here for many central laboratory providers.
One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.
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