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 Expert  729312

Expert in Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market


Available for your Consulting and Expert Witness Needs

India
Education Work History Consulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Expert's Firm for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs.

Ms Expert was the Medical Devices Reviewer for the Central Drugs Standards Control Organisation (CDSCO), the regulatory body (FDA) of the Govt of India during 2007-2008 and for IVDs fron 2002-2006 and Asst Director with the Food Safety and Standards Authority of India from 2009-2010. She has quit the government of India in May 2010, and is now the CEO of a proprietorship firm promoted by her son that provides Independent Indian Representation alongwith regulatory consultancy services and marketing strategies to Medical Devices/ IVDs/ Drugs and Cosmetics Manufacturers worldwide to sell their products in India.

Ms Expert's expertise in preparation of documentation required for approval by the Indian Regulatory Body i.e. the CDSCO ensures speedy approvals to import and market Drugs , Medical Devices and IVDs in India.

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foreign medical device regulation


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution  
1989   M.Sc (Organic Chemistry)   Applied Sciences   University of Pune  
1987   B.Sc (Chemistry Honours)   Applied Sciences   University of Pune  

Work History:
Years   Employer   Department   Title   Responsibilities

2010 to

 

(Undisclosed Consulting Company)

 


 

CEO

 

Has taken over as CEO of Expert's Firm , a regulatory Affairs Consultancy firm from May 2010.

2009 to

 

(Undisclosed Consulting Company)

 

Food Authority

 

Asst Director

 

She was instrumental in setting up the Establishment Division of the newly formed autonomous body of the Govt of India, the Food Safety and Standards Authority of India. She was involved in the framing of revised regulations and licensing procedure for food establishments under the Food Safety Act,2006.

1995 to 2008

 

(Undisclosed Consulting Company)

 

New Drug Approvals,Medical Devices,IVDs,Blood Banks

 

STA

 

She has been the Reviewer for Medical Devices from 2007-2008, for IVDs from 2002-2006, Blood Banks from 1995-2001.

She has been instrumental in developing and introducing various Policy decisions of the CDSCO, Govt of India including Regulations for Blood Banks and Import Registration for Drugs and related products.


Government Experience:
Years   Agency   Role   Description
2009 to 2010   Food Safety and Standards Authority of India (FSSAI)   Assistant Director   She has set up the Establishment Division of the newly formed FSSAI and also associated with framing of regulations for licensing of Food establishments.
1995 to 2008   Central Drugs Standards Control Organisation (CDSCO)   STA/Reviewer   She was the CDSCO Reviewer for grant of approvals, marketing permissions,registrations,licences in various Divisions viz Medical devices (2007-2008),IVDs(2002-2006),Blood Banks (1995-2001).
1990 to 1994   National Aids Control Organisation(NACO)/DGHS   Incharge Blood Safety   She was the nodal point for setting up and implementation of the Blood Safety Programme of NACO since its inception in 1992 and with the Emergency Medical Relief Division of Directorate General of Health Services prior to 1992.
1986 to 1989   Ministry of Defence   Administrative Executive   She was instrumental in the deployment and transfer of various categories of Defence officials.

Consulting Services:
Selected Consulting Examples:
  • Expert's Firm is the Authorised Indian Agent of Invatec Italy, a Medical Device manufacturer.
  • Provides Regulatory Affairs Consultancy to Medical Device Companies such as Abbott Medical Optics, Smiths Medical, Nobel Bio Care, Medtronic Invatec, Medtronic-ATS ,Wipro GE and various Indian manufacturers.
  • Provides Regulatory Affairs Consultancy for IBA Belgium (radiopharmaceuticals).
  • Provides Regulatory Consultancy to Cosmetic firms for import and marketing in India(Oriflame SA Luxembourg).
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
She is the CEO of a consultancy which provides all solutions to introducing any product regulated under the Drugs and Cosmetics Act in India which includes Medical Devices, Drugs, IVDs and Cosmetics.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language  
English  
Hindi  

 

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