Expert Details
Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market
ID: 729312
India
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.
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.
Employer 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).
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1989 | Degree: M.Sc (Organic Chemistry) | Subject: Applied Sciences | Institution: University of Pune |
| Year: 1987 | Degree: B.Sc (Chemistry Honours) | Subject: Applied Sciences | Institution: University of Pune |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2010 to Present | Employer: Undisclosed | Title: CEO | Department: |
Responsibilities:Has taken over as CEO of Employer a regulatory Affairs Consultancy firm from May 2010. |
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| Years | Employer | Title | Department |
| Years: 2009 to Present | Employer: Undisclosed | Title: Asst Director | Department: Food Authority |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1995 to 2008 | Employer: Government of India | Title: STA | Department: New Drug Approvals,Medical Devices,IVDs,Blood Banks |
Responsibilities: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. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2009 to 2010 | Agency: Food Safety and Standards Authority of India (FSSAI) | Role: Assistant Director | Description: She has set up the Establishment Division of the newly formed FSSAI and also associated with framing of regulations for licensing of Food establishments. |
| Years: 1995 to 2008 | Agency: Central Drugs Standards Control Organisation (CDSCO) | Role: STA/Reviewer | Description: 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). |
| Years: 1990 to 1994 | Agency: National Aids Control Organisation(NACO)/DGHS | Role: Incharge Blood Safety | Description: 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. |
| Years: 1986 to 1989 | Agency: Ministry of Defence | Role: Administrative Executive | Description: She was instrumental in the deployment and transfer of various categories of Defence officials. |
Language Skills
| Language | Proficiency |
|---|---|
| English | |
| Hindi |