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Regulatory Writing Services-Pharma | Biotech | Medical

We offer a wide range of high quality regulatory and clinical writing services and also compliant to the regulations that are required to be followed. We ensure that all our writing documents meet your medical, legal and regulatory requirements. Our regulatory writing is structured in ways that are of the most acceptable norms. Our writing reflects clarity and succinctness, and we adhere to timely delivery of your documents. Our team of regulatory writers are versatile and experts in the field with more than substantial experience. We have experience with an extensive range of therapeutic areas including oncology, vaccines, diabetes, endocrinology and neurology. Medical writing Experts present to you a top notch professional writing service in a niche market. Our regulatory writing services includes Phase 1 to 4 clinical study reports (CSRs) Protocols and protocol amendments Informed Consent and Patient Brochures Patient Safety Narratives and patient profiles Common Technical Document (CTD) for clinical and non-clinical procedures In-House Data Summaries Safety Surveillance Plan Case Report Forms We ensure to provide the required assistance to you from day one till the very final completion that ends with your regulatory submission and acceptance. Our writing remains unparalleled so avail our regulatory writing services now!

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RegAffair Solutions Limited: - will provide below services to pharmaceutical companies / CRO companies; Generic product development strategy, planning and execution Regulatory strategy and intelligence services Health authority/agency consulting, advisory and liaison Regulatory submissions Preparation of CMC sections for DP and DS, specific to markets Preparation of documents for variation packages to close the GAPs as per the strategy Strategy development to remediate GAPs for the assigned projects Preparation of module 1, module 2 & module 3 documents for submission Will review and commented on the module 3 regulatory dossiers for accuracy of the content for submissions Preparation of initial MAA generic applications (MRP, DCP & National), regulatory compliance and conformance, post-marketing maintenance activities like variations, renewals and query replies etc.

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