Regulatory Science & Product Development Experts helping customers
Commercialise Products | Reduce Time to Market | Achieve Compliance | Grow Business
Regulatory Reporting
We use a blend of proven operational methodologies, processes, Standard operating procedures (SOP’s), technology, infrastructure, tools, templates and the ‘right’ kind of human intellect to deliver our projects consistently on time and agreed upon quality guidelines to generate significant ROI. The final goal being Affordable, Consistent, high-quality data (Source-verified, Accurate, Accessible, Reproducible) without compromising your timeline or budget.
At Vyomus Consulting, our team of knowledgeable regulatory professionals offer expert consulting and provide optimal solutions throughout the clinical development cycle – during different phases of Clinical Trials and Post-Marketing phase. We design and implement regulatory reporting projects specifically tailored to your organization’s requirement in terms of budget and timelines.
Our overall experience includes over six hundred preclinical, clinical trial approvals, product registrations, marketing authorizations, import and marketing authorizations, manufacturing and marketing authorization and transactions covering a large number of therapeutic and product categories.
We also have the capability to function as a “non-competing tactical satellite” or as a “non-competing extension” or division of each sponsor’s business. Critical reporting functions can remain in-house under direct supervision of the sponsor, while process-driven aspects can be outsourced to expedite processing, reconciliation, reporting and query resolution. Rest assured, the quality of delivery would be accepted by International regulatory authorities.
Industry focus :Pharmaceuticals, Medical Devices, Cosmetics & Wellnes, Food & Nutrition.
- Independent Scientific and Regulatory review of Preclinical reports, Clinical reports, CMC reports, Safety reports, Protocols, Investigator brochures, Patient information leaflets, Clinical Trial Applications (CTA’s), Investigational New Drug Applications (IND’s), Biologics, Biosimilar Licensing Applications (BLA’s), New Drug Applications (NDA’s), Subsequent New Drug Applications (sIND’s), Marketing Authorising Applications (MAA’s), Common Technical Documents (CTD’s), Drug Master Files (DMF’s), Risk Management Plans etc.,
- Regulatory reporting to regulatory authorities, Investigators, Ethics Committees.
- Periodic Safety Update Reporting (PSUR’s).
