Regulatory and Medical Services
What we provide?
Regulatory and Medical Writing Services at NextBio Research Private Limited are robust offerings that fully support drug research and development, both within and across the organization as well as standalone, independent value additions that are tailored to meet specific client requirements.
The Scientific and Medical Writing team at NBR is adept in the preparation of objective, comprehensive and reliable clinical trial documents for regulatory submission that meet internal requirements and specifications, and standards set by the relevant regulatory authorities. All trial-related documents meant for regulatory submission are thoroughly reviewed by an independent Quality Assurance (QA) team prior to their final release.
Our complete spectrum of Medical and Scientific Writing expert services is available in a timely and cost -effective manner. The Scientific writing team in co-ordination with the Pharmacokinetics and Biostatistics team delivers high quality trial documents that are regulatory ready.
Our Regulatory services team takes an active role in supporting our sponsors in all aspects of clinical development planning, positioning strategies, integrated planning and management, and preparation of dossiers as well as submission of these documents to regulatory authorities and ethics committees for a smooth approval process.