We are REGULATORY SPECIALISTS. A team qualified and experienced in Medical Device, Pharmaceuticals, Cosmetics, Food and Nutraceutical regulatory practice, working across the America, Europe, Middle East and Asia-Pacific. Despite the reach and capabilities of our offices, we are large enough to guide fortune 500 companies and small enough to guide individually owned companies, making us one of the most accepted regulatory specialists. No wonder, the proof of our ability is answered by our massive number of customers which is increasing day by day mainly from clients reference.
What is CE Marking and why CE Marking for Medical products in the European market.Classification of Medical Device
How the Medical Device are classified as per MDD ( CE Mark) requirement ? What are the different class of Medical Devices?Technical File
The Technical File to be prepared for the Medical Device you are planning for CE Mark. It contains all the information relevant toNotified Body
Why notified Body is required for CE Certification? How can we contact them and what is the fees ? How can we contact them?CE Mark Consultants
What is the role of consultant? How they can help you with the CE Certification process. What will be the cost? How the consultants to be selectedMedical Device Export to USA
US FDA Registration and product listing is mandatory. How and what time theOwn-Brand Labelling ( OBL CE Certification)
What is OBL CE Certification? How to Certify? Who is OBL and who is OEM?
All medical products applying for CE Certification has to test the medical device as per Harmonized standards. How and where the test to be conducted? What are the test to be conductedSoftware CE Marking
Software system that has been developed for the purpose of being incorporated into a Medical Device needs CE LogoEN ISO 13485:2012 / ISO 13485:2003
Why Implement ISO 13485 for CE Certification process? How can we implement ISO 13485? How long it will take and what will be the cost?European (EU) Authorized Representative
An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. It is required for all non european countries applying for CE Marking.US FDA 510k
510(k) is a submission made to USFDA to demonstrate that the Medical Device to be marketed is safe and effective as others of similar intended use21 CFR 820
This is a QMS / GMP requirement and to be implement by all the manufactures based on the product category. How long the process and what will be the cost
How to set up world call manufacturing facility as per regulatory norms. What are the requirements? How a consultant can help.US FDA Registration ( Drugs, API, Labs, Sterilizers)
Those interested to market Finished Formulations, API, Homeopathic Drug, Laboratory Service, should register with US FDA,s Centre for Drug Evaluation and Research (CDER).NDC Labeller code (National Drug Code)
National Drug Code is a ten digit unique product identifier number for human drugs. How to get the numberUS FDA Drug Listing
Listing to be done for all drugs planned to sell / Distribute in the United States of America. What is the procedure? How much to cost?US Agent service (US representation services)
US FDA enforces the need for foreign-based Food, Drug and Medical Device companies without a location in the United States to register with the FDA after appointing a "U S Agent". How can we contact a US Agent? How much it will cost?
A Drug master File is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs. How a consultant can help? How much it will cost?US DMF Submission Fees
Two activities involved are DMF preparation and US Agent Service. We can provide both services for all wishing to have DMF number from US FDA.Drug Establishment Registration with FDA
FDA's Centre for Drug Evaluation and Research (CDER) is evaluating and approving new drugs before they are sold in the US. If your company is interested in selling prescription and non-prescription or over-the-counter (OTC) drugsFDA Drug Registration and Listing
Domestic and Foreign drug manufacturing and distributing firms must at the time of drug establishemnt registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distributionNDC Labeller code (National Drug Code)
NDC code request to FDA should submit in SPL (structured Product Labelling) format via FDA ESG (electronic submission gateway)
Federal Food, Drug, and Cosmetic Act (FD&C act) and the fair Packaging and Labelling insists manufactures and importers toUS FDA Establishment registration
All food and nutraceutical exporters has to register with US FDA. Our consulting service helps to comply with FDA bioterrorism act requirements by?Testing of Food
Test the product as per standard and make sure the safety and quality of the productUS FDA Facility Registration fees
We offer complete solution for US FDA registration with US Agent service. Our fees are very lowGMP / 21 CFR 110 requirements for US FDA
Code of Federal Regulations 21 CFR Part 110 requirements for Current good manufacturing practices (GMPs) for food manufactures
Any commercial food manufacturer processing and packaging low-acid canned foods and acidified foods must registerFood Additives
A food additive is any substance added to food. directly or indirectly to becoming a component or otherwise affecting the characteristics of any foodFDA Certificate
Manufactures, Exporters and Traders across the globe are curious to have an FDA CERTIFICATE in the name of the company. But this is not possible. US FDA will not issue any kind of FDA Certificate to any kind of organizationUS FDA Food Contact Substance (FCS)
Manufacturers can issue a compliance certificate in compliance with Section 303 c (2) of the Federal Food and Drug Cosmetic act. This section clearly states that penalties are laid down by violation to the act.