Fast and Reliable Medical Device Regulatory
About Our Company
Mn Solutions operating in the regulatory services for pharma industry is an India based company par excellence, and now offering one of the best medical devices regulatory services. We have been operating in this industry since last more than 10 years and take pride in a highly satisfactory client base across the globe.
Our unique end-to-end medical devices regulatory services portfolio entails the following steps to provide regulation for the proposed product;
a. Pre-Registration Consulting
b. Requisite Documentation Kit for proper documents submission
c. In-process facilitation services
d. Final Regulatory presentation and approvals
e. Post Approval consulting services
f. Client Feedback
We provide medical devices regulatory services to all the products covered under Indian Drugs & Cosmetics Act. Our medical devices regulatory services follow a systematic approach and well-defined regulatory pathway for clear understanding.
Under our regulatory compliance services for medical devices we follow a specialized and a customized workflow chain that includes;
a. Fact Sheet Template
As a very first step in our specialized approach we collate and gather requisite information regarding our client and their proposed product for approval. This helps us to understand the regulatory requirements applicable on the proposed product. This further helps us in providing customized approach to our clients.
b. Documentation Checklist
At this stage based on the above informative details we provide a detailed document requirement template to our valued customers. This dossier helps the customers to provide specific technical documents that are directly relevant to the required application.
c. Gap Analysis
Based on the above documents our experts carry out an in-depth gap analysis with due diligence through our gap analysis template to ensure proper submission as per guidelines.
d. In-Process Assistance
At this stage of the product approval we assist our clients to provide further requirements if any to the regulatory body for compliance. This facilitates and streamlines the entire process for our customers.
e. Post Approval Submissions
We guide our customers for PCN (Post Change Notifications) filings to maintain the regulatory compliance.
We take pride in the fact that based on our customized approach we are able to achieve a high satisfaction rate for our valued customers across the globe. We also feel privileged in partnering with some of the best organizations and related bodies like AIMED, SODRAP, FICCI, Indo-Mexican Chamber of Commerce, Gerson Lehman Group (Consulting Management Platform), Ubi-France worldwide.
Our Business Collaboration: Arazy Group, Phamalik Consulting, UK, Member-DKNSB (Medical Device Consulting Group)
MN Solutions is a team of professionals and progressive regulatory affairs consultants with expertise and skills in Regulatory Affairs, contract manufacturing tie-ups, consulting, research facility tie-ups, channel development on Pan-India basis.
- MEDICA13-16 Nov 2017, Germany
- IOACON 26-31 Dec 2017, Indore (India)
- NSICON 30-Nov-3rd Dec 2017, Nagpur (India)
- Arab Health 29th Jan-1st Feb 2018, Dubai