Regulatory Science & Product Development Experts helping customers
Commercialise Products | Reduce Time to Market | Achieve Compliance | Grow Business
Regulatory Submissions
Implementation of an appropriate regulatory strategy is critical to efficient drug development and the successful approval of products. In addition to strategic capability our regulatory team has practical experience in implementing these strategies through submissions in a wide range of products and procedures.Regulatory input during the entire product life-cycle has a tremendous impact on marketing, new claim development, supply chain management and every aspect of the post-marketing phase.
Vyomus Consulting has the expertise and experience in the preparation, management and submissions of all types of regulatory documentation associated with product development, approval and maintenanceincluding application amendments and maintenance, Supplement preparation, maintenance and submission. We provide regulatory expertise and resources through all stages of product development to enhance submission preparation and achieve faster product approval.
Vyomus Consulting has significant experience in helping customers maintain and enhance their valuable product licenses, and deliver strategic and practical support for all aspects including variations, supplements, labelling changes, renewals and extension applications.
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.
Industry focus :Pharmaceuticals, Medical Devices, Cosmetics & Wellnes, Food & Nutrition.
- Prepare, review, maintain Preclinical development plans, Clinical development plans, Protocols, Investigator brochures, Patient information leaflets, Clinical Trial Applications (CTA’s),Investigational New Drug Applications (IND’s), Biologics, Biosimilar License 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.,
- Prepare, review, maintain Product labelling for Clinical trial supplies, Biologicals, Biosimilars, Vaccines, Advanced therapeutic products, Branded & Generic products, Veterinary products, Medical Devices, Diagnostics, Cosmetics, Insecticides & Pesticides etc.,
