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News and Info

07 Jun

mdi Consultants Inc. and Operon Strategist(India) announce strategic alliance!!!

mdi Consultants Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries. mdi Consultants, Inc., is a Medical Device Consulting, U.S. Agent, CE mark, ISO, Pharmaceutical and Quality Assurance, Regulatory Consulting company and Authorized Agent. The “Operon Strategist” is consultancy firm working towards the

18 Dec

Lack of consistency by the US FDA on its own labeling policy…

Present Scenario: The US Food and Drug administration is appealing for feedback on its proposal to bring into line its medical device labeling requirements with those in the EU by permitting the use of standardized stand alone symbols on device labels providing these are clarified in a supplementary symbols glossary. Regulations in the US at

04 Oct

Federal Government Shutdown coming down very hard on the Food Safety & the FDA!!!!

Background: The Department of Health and Human Services (HHS), of which the Food and Drug Administration (FDA) is a part, recently published “Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations.” Essentially, this Plan is the SOP for how HHS and FDA will operate under the current partial government shutdown. Under this

06 Aug

Health Canada to Use US FDA’s Electronic Submission Gateway (ESG) for eCTD Submissions!!!

In the future, you will be able to submit applications to Health Canada through the US Food and Drug Administration’s gateway. Health Canada is collaborating with its U.S. regulatory counterparts to reduce regulatory burden for health products, and to move closer to an automated environment for the exchange, review and management of information supporting the

12 Dec

Announcing a STRATEGIC ALLIANCE

LOK-RUS and mdi Consultants Inc. are pleased to announce a strategic alliance. LOK-RUS provide services to the Russian Market including Registration, Translation, Manufacturer Agent & Local Authorized Agent Representation and aim to offer our customers access to other predominant markets as well. mdi Consultants Inc. is a leading provider of quality assurance, regulatory compliance and

mdi consultants Visit to El Salvador
Dec

Visit to El Salvador

An Unexplored Opportunity for Pharmaceutical and Medical Device Industries December 4-7, 2012 Alan Schwartz, Executive VP, & Aditya Sukthankar, Associate mdi Consultants Inc., Great Neck, NY, USA Five years ago, U.S. Agency for International Development (USAID) asked mdi Consultants to visit Nicaragua to review the country’s industries, evaluate their potential for expanding the investment and

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