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 catalyzing and ensuring the strategicdevelopment of the clients in the areas of Regulatory approvals , Quality Assurance, Quality Control, Licensing and Marketing authorization for the Medical Devices industry, Pharmaceuticals, R & D Centers, CRO’s, Laboratories and Hospitals. We undertake turn key projects, annual regulatory contract as well as functions on the customized packages as per the need of the client.
With the recent visit of the FDA commissioner Margaret Hamburg, the regulatory environment has become pretty stringent in India and the pharmaceutical companies are seeking help either from local or overseas consultants to help them sail smoothly to abide by these regulations. Keeping all these factors in mind, we are pleased to announce the professional and operational association with Operon Strategist (India) to all of our clients. We feel that this symbiosis will extend our horizons overseas (India) and that we would be able to cover unexplored potential of the Indian medical device, food and drugs companies who wish to enter the US market and want comprehensive FDA regulatory assistance and advice.
A glimpse of some of the services that Operon Strategist provide include but not limited to the following:
Turnkey manufacturing, testing facilities set up, Assist in Regulatory approvals like 510(k), CE for Medical devices. Quality Management systems implementation and GAP analysis like ISO 9000, ISO 13485, cGMP implementation and GAP analysis for implementation as per requirements of 21 CFR part 820 for Medical device industry, cGMP implementation and Gap analysis for regulatory approvals of USFDA, MHRA, EU-GMP, CDSCO etc., Audit assistance in the USFDA, MHRA, EU-GMP etc. audits., Drug product approval and dossier preparations: DMF’s, CTD’s, eCTD etc. US and EU representatives, Assistance in Validations: Equipment (Sterilizer, Tunnel, Hot air oven etc.), Utilities (Water system, HVAC system) validation, Process validation, Cleaning validation, Microbiological validations etc.
We feel that with this alliance, mdi and Operon would be in a position to provide both US and Indian companies who want to expand their markets to INDIA and the USA. This Alliance will be a strong association for both companies in the USA and India.
Our US office contact info:
mdi Consultants Inc.
55 Northern Blvd. Suite 200
Great Neck, New York – 11021.
To contact our Indian Counterpart Operon Strategist please find the info below:
Mr. Anil Chaudhari
Office address :
13, “A” Tower,
Third Floor, Sagar Complex,
Kasarwadi, Pune: 411 034.
Skype : Operonstrategist