Expertise in tailormade study protocols, in line with the sponsor’s requirements and applicable regulatory guidance. Our medical writing services are in full compliance with applicable regulatory requirements.
With onboard panel on medical professionals our team is able to support quality study conduct with highest medical integrity.
RYT Lifesciences offers comprehensive regulatory services, guiding you from the initial regulatory submission to securing marketing approval for your drug. In the role of a regulatory affairs associate, we serve as a vital intermediary between our sponsors, its products, and regulatory authorities. Leveraging our expertise in scientific, legal, and business domains, we ensure that products developed, manufactured, or distributed by the client comply with the requisite legislation. With robust understanding of global regulatory affairs, our team is a reliable partner for regulatory affairs requirements.
Project management plays a critical role in meeting study and regulatory requirements within specified timelines. We develop and uphold detailed project and science plans, reports, work breakdown structures, Gantt charts, resource plans, and budget plans to facilitate the seamless execution of cross-functional projects across various organizational units. Additionally, we create resource forecasts, monitor actuals, and assess variances for the assigned projects to ensure efficient project management. Our highly experienced project managers make sure that the study is planned well and provide oversight to day to day study conduct to ensure study is progressing as planned.
We offer pre-approval and post-marketing pharmacovigilance support, recognizing the vital role of managing safety data and adverse events throughout the entire product life cycle. This approach is essential to mitigate risks associated with clinical studies and investigational drugs. Our innovative strategy ensures a comprehensive and proficient management of safety data. We deploy efficient electronic systems to enhance data accuracy and reduce inconsistencies. Placing subject safety at the forefront, we provide a wide range of pharmacovigilance services and tailored solutions. Our approach involves effective evaluation and thorough industrial-leading analysis to minimize associated risks in both clinical study conduct and post-marketing phases.
We have a highly skilled talent pool, who have worked on Phase I-IV trials for a variety of therapeutic areas including Biologics and Biosimilars. Team works with stringent quality procedures including peer QC & independent QA at various stages of documentation & data processing. Efficient and tested processes with detailed documentation including SOPs, working procedures & study specific documents to comply with ICH standards, national regulations & guidelines.
In the clinical development process at RYT Lifesciences, we transform scientific knowledge into practical medicine. Data derived from fundamental research, pre-clinical pharmacology, and safety studies undergo rigorous evaluation in clinical trials. This thorough assessment determines whether scientific theories effectively translate into valuable and impactful therapies for patients.
Effective clinical monitoring is crucial for the successful execution of a clinical study in accordance with the protocol, ICH GCP, and relevant regulatory guidelines. As your partner, we serve as the primary communication link between the sponsor and the investigator. Our role involves offering support to investigators, ensuring proper conduct and documentation of the trial.
