REGhelps for EU MDR & US FDA 510k Regulatory Helps
Two highly regulated markets “Europe” and “America”. Manufacturing, Importing and Post market process is very complex and tedious process and lot of documentation. Small, medium and large scale manufactures always look for external support and guidance always to overcome the complexities. Most of medical device manufacturers in Europe and America and also manufactures from other foreign counties thereby outsourced the work to experienced hands. REGhelps is one such regulatory service company serving customers for many years successfully.
REGhelps for US FDA Registration Service for Food, Drugs & Medical Device
In United States of America law is enforced by Federal Food and Administration (FDA) related to manufacturing, Importing and Marketing of Drugs, Medical Device, Cosmetics, Food, Nutraceuticals, Active Pharmaceuticals, Biologicals, Alcoholic beverages, Nicotine etc.
REGhelps for US Agent and European Authorized Representative Service
Medical Device Entry to Europe is permitted only after producing the Declaration of Conformity (DOC) and or CE Certificate issued by a Notified Body. A declaration of conformity is prepared with device information and EU Representative or European Authorized Representative address and contact information. This is mandatory by Law and a regulatory Requirement which manufactures has to follow during export to Europe.
The FDA made it mandatory to have a US FDA Agent for all foreign exporters planning to marked any if the regulated Items for Human consumption.
REGhelps for MDSAP, ISO 13485, 21 CFR 820 Regulatory Helps
Quality is NOT a onetime activity. No matter who does it, when it manufactured, what materials used for the manufacturing, what equipment’s used, what was the manufacturing and Infrastructure condition. QUALITY is Important for all the products manufactured today and anytime. Quality Management System is an essential part and should be implemented by all especially in the field of Food, Pharmaceuticals and Medical Device. Proper Implementation of QMS assures consistent quality. Here is REGhelps role. We are regulatory consultants for MDSAP, ISO and 21 CFR 820 good manufacturing
To be an independent credible and professional Regulatory Consulting company that treats all our customers fairly in all of our dealings with us. We try to build awareness amongst our customers of the regulatory role we are going to perform with your team and the work we do in advance to avoid future misunderstanding. We believe people who work and serve customers in our company should have the sufficient knowledge and hands on updated regulatory information. They are key force in achieving early certification and clearance from regulatory bodies. This belief should be our cornerstone of an effective regulatory consulting service that benefits the customers and ultimately leads to customer referrals and economic growth of our company.
- Most projects completed without the presence of consultants onsite, this helps reduce huge travel and allied cost.
- Business / Documentation happens in the silicon Valley of India, the Bangalore. The largest technical pool of consultants and clinical writers works 24 x 7, 5 days a week.
- Across Globe regulatory outsourcing a common practice and find India a hot destination with economic pricing and tax benefits
- Documentation move on cloud. No matter where you are!!!