Regulatory Consulting & Services
The business environment for regulated industries is increasingly being affected by national and international regulations that demand specialised knowledge. Vyomus Consulting can bring that knowledge, experience and expertise to help customers operating in the regulated sectors.
Developing and Implementing an optimal, effective regulatory strategy is critical for attaining efficient product development leading to successful commercialisation of products. Vyomus Consulting has significant experience & expertise in understanding customer challenges and helping them understand regulatory requirements along with developing and implementing optimal, efficient, effective regulatory strategies leading to first-cycle product commercialisation approvals in India.
Our experienced, senior regulatory professionals provide Regulatory and Product Development expertise through all stages of the product commercialisationlifecycle to enhance regulatory submission preparation and achieve faster regulatory, business outcomes, leading to enhanced access to Markets and Opportunities.
Integrating Science, Regulations, Measurable Business outcomes and combining local knowledge with global standards, we move beyond providing expert advise to get your project off the ground, move at a fast pace and achieve faster approvals.
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.
Whether your company is a start-up, small to mid sized or a global conglomerate, we provide regulatory & product development support you need for effective & efficient commercialisation of your products leading to faster access to local Markets and Opportunities.
Industry focus :Pharmaceuticals, Medical Devices, Cosmetics & Wellnes, Food & Nutrition.
Our regulatory group specializes in rescuing regulatory projects which need specific consultation in restructuring, restrategising and or reimplementing.
Market Authorisations, Clinical Study Approvals, New Drug Approval, Labelling Services, Regulatory Strategy, Regulatory Reporting, Regulatory Submissions, Regulatory Intelligence, Authorised Agent Services, Market Access.
| Regulatory Intelligence |
Regulatory Strategy |
Regulatory Submissions |
On-Demand Consulting |
|---|---|---|---|
| Product specific requirements |
Scientific & Regulatory assessment | Market Authorisations, Clinical Study Approvals, New Drug Approval |
Regulatory insight & Clarifications |
| Precedents & current thinking |
RegulatoryStrategy & Roadmaps |
CTA, IND, BLA, NDA, MAA, CTD, DMF, Protocols, Labels & SPC’s, Investigator brochures |
Strategies & Solutions |
| Product specific RI Status Document |
Preclinical & Clinical Development Plans |
Approval Maintenance | Rescue regulatory projects |
