![]() ![]() Regulatory medical writing involves writing documents. Medical writing can be classified into two types: Regulatory medical writing and Educational medical writing. Our documents follow ICH guidelines are written to be fully compliant with all regulatory requirements. Medical writing involves creating well-structured scientific documents that include clinical research documents, content for healthcare websites, health magazines, journals and news. Global Regulatory Medical Writing Services Medical Writing Solutions Forward-thinking medical and regulatory writers that produce cohesive and scientifically-accurate documents. ![]() We have written clinical trial protocols, clinical study reports, briefing documents for regulatory meetings, and Investigator Brochures. Remote Senior Medical Writer opportunity in the oncology space Collaborate on preclinical, clinical and regulatory document development Write, edit and. Our medical writers are here to assist you in the drug development lifecycle across Phase I to Phase IV. Representation of clients with regulatory authoritiesįrom the early stages, Sainalytics medical writers are involved in critical aspects of your projects and we have clinical development expertise across all phases of drug development.Sponsor / FDA Liaison / Representation, Document Preparation, Review & Submission.Investigational New Drug Application (IND).The Sainalytics team has developed a deep understanding of the intricacies of the regulatory process that only comes with years of working within the FDA, and numerous pharmaceutical, device and biotech companies, and various contract research organizations and other vendors. What sets Sainalytics apart from other CROs is that we only employ the most experienced personnel. 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.Ī well designed and implemented regulatory strategy is critical to getting a product to market quickly and in a cost effective manner. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Each writer is a graduate-level life science scholar. Excellent communication, strong organization skills. 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. Experienced regulatory and medical writer, with a diverse background in the pharmaceutical industry, specializing in clinical study documents, CMC investigations using root cause analysis, quality control data review, drug product and drug substance stability programs, and compendia testing. ![]()
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