Regulatory Consultancy Services
Regulatory Services India (RSI) is a leading regulatory consultancy in India, with over 10 years of experience in helping medical devices, IVD and Cosmetics companies register their products with the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India.
We are a team of regulatory experts who have worked extensively with multinational companies as well as Indian Pharmaceutical Companies. Our team can help you develop an optimal regulatory strategy for your product and provide comprehensive guidance throughout the registration process.
With RSI, you get the assurance of a hassle-free journey to start marketing your medical devices all over India
Regulatory Strategy
Regulatory Strategy for Medical Devices introduction into India
- Portfolio Analysis
- Interpret regulatory requirements & provide opinions.
- Design the right strategy based on experience.
- Identify potential problems & provide solutions
- Regulatory Due Diligence Report preparation.
PREVENT COSTLY DELAYS WITH THE RIGHT STRATEGY
Regulatory Application Submission
Registration Application Submissions to CDSCO
- Develop and / or review regulatory documents.
- Validate dossiers.
- Submit applications for Voluntary Registration & Import License.
ENSURE ONTIME & QUALITY SUBMISSIONS
Registration Approval
Facilitate Registration approval process
- Technical support for scientific meetings with regulators.
- Formulate & respond to regulatory queries.
WORKING CLOSELY WITH CLIENT FOR TIMELY APPROVALS
Post Registration
Post registration support for:
- Labeling recommendations & regulatory compliance.
- Post registration compliance reporting obligations.
- Advise on Impact, if any, due to regulatory changes.
PRO-ACTIVE POST REGISTRATION SUPPORT
Additional Services
LMPC Registration for Medical Device Comp.
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