ClinRevolt: Your Partner in Pharmaceutical Innovation
At ClinRevolt, we are dedicated to advancing healthcare through our comprehensive pharmaceutical services. Our mission is to support researchers, clinicians, and pharmaceutical companies in bringing safe and effective medications to market efficiently and responsibly.
Experienced Team
Our professionals bring years of industry expertise, ensuring high-quality service and support.
Patient-Centric Approach
We prioritize patient safety and efficacy in every project, striving to enhance therapeutic outcomes.
Innovative Solutions
We leverage cutting-edge technology and methodologies to streamline processes and reduce time-to-market.
Clinrevolt Services
Navigating Change in Pharmaceutical Care
Clinical Trial Management
- We specialize in protocol design, review, and approval for all types of studies, including Investigator Brochures (IB) and Informed Consent Forms (ICF), as well as post-authorization studies.
- Our services also encompass developing study monitoring plans and safety monitoring plans to ensure compliance and safeguard participant welfare throughout the research process.
Regulatory Affairs
We offer end-to-end dossier preparation for global markets, authoring all regulatory documents for vwe offer end-to-end dossier preparation for global markets, authoring all regulatory documents for various products at every stage, including post-approval management and handling all types of variations. Additionally, we ensure compliance with the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and Identification of Medicinal Products (IDMP) through accurate entry and maintenance.
Pharmacovigilance
- Pharmacovigilance systems that include safety databases, quality management systems, and the Pharmacovigilance System Master File, while overseeing drug development safety activities such as SUSARs and DSURs, and addressing health authority requests.
- We also manage pre- and post-approval activities, including risk management plans, adverse event reporting, signal management, and ongoing monitoring to ensure the safety and efficacy of products throughout their lifecycle.
Medical writting
- We provide expert medical writing services, including non-clinical and clinical overviews and summaries, ensuring clear communication of safety and efficacy for regulatory submissions.
- Our team also prepares Addendums and standardized documents like CCDS and CCSI to keep all information current and consistent for global communication.
- We create ACOs to incorporate new data or product changes, ensuring information remains current.
Discover the Power of ClinRevolt Healthcare
Join us in revolutionizing the pharmaceutical landscape. At ClinRevolt, we are committed to empowering your success through our tailored services.
Let’s work together to bring the next breakthrough in medicine to life.