Expert Details
pharma, regulatory, cosmetics, biosimilars
ID: 735412
India
In light of current drug regulations ( Drugs and Cosmetics act 1940 and Rules 1945 along with with the applicable contemporary guidelines such as ICH/ WHO/ PICS ) and the science ( technical evaluation)
As part of the evaluation process, the expert is routinely examining the administrative, Chemical manufacturing and control, clinical data in CTD format. Till this date, the expert has processed as many as 50 proposals of market authorization of new drugs (including biosimilars ) and more than 50 proposals of Clinical Trials. He can assist the prospective clients on regulatory matters ( regulatory dossiers submissions to the health authority for registration, guidance on regulatory pathways, market intelligence, overall market trends, import procedures through the post offices, etc. His primary area of interests includes biosimilars, cosmetics, biologicals, and Clinical Trials, etc..
Apart from above, Expert is willing to take any consultation projects which are relevant to his profile.
1. A US-based client was looking for intelligence regarding a formulation for external application after thorough research, a complete report was submitted describing the exact regulatory status of the drug in the country. Type of consultation - Email and telephonic feedback. No of Hours required -08.
2. A Europe based client was looking for the detailed procedure regarding filing a complete dossier for registration of a new drug in India. Based on the information submitted by the firm, thorough research was done in light of Drugs and Cosmetics Act and Rules thereunder a complete regulatory pathway was provided to the firm giving vital feedback on timelines for various steps involved. The consultation involved 50 minutes of telephonic consultation followed by a crisp summary of all probable steps ( based only on data available in public domain) furnished through email feedback. Duration of Telephone consultation 50 min
Written Summary work -3 hrs.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1992 | Degree: Master of Pharmacy | Subject: Pharmaceutical Sc | Institution: Nagpur University, India |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2003 to Present | Employer: Undisclosed | Title: Senior Technical Assistant/Technical Officer | Department: Biologicals/ Import |
Responsibilities:• Reviewed critically and submitted technical files pertaining to import and export of pharmaceuticals, new drugs, therapeutic proteins, medical devices, etc• Worked in a multi-tasking environment for issuing various regulatory approvals and licenses, No Objection Certificates, etc • Reviewed critically and submitted technical files pertaining to import and export of pharmaceuticals, new drugs, therapeutic proteins, medical devices, etc |
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| Years | Employer | Title | Department |
| Years: 2000 to 2001 | Employer: Genpharm Inc | Title: Stability Assistant , (Volunteer Position) | Department: |
Responsibilities:• Performed routine optimization, documentation, and verification of analytical instruments that includes analytical and microbalances• Stored, scheduled and reproduced the stability samples • Carried out stability documentation duties • Controlled, recorded lab samples and other technical assistance in a strict GMP environment |
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| Years | Employer | Title | Department |
| Years: 1997 to 2000 | Employer: Government College of Pharmacy, India | Title: Technical Associate | Department: |
Responsibilities:• Taught undergraduate courses in Organic Chemistry, Medicinal Chemistry, General Pharmacy as theory and practical sessions• Participated in development of departmental plans, policies and technical research projects |
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| Years | Employer | Title | Department |
| Years: 1992 to 1997 | Employer: Wockhardt Pharmaceuticals, India | Title: Laboratory Analyst | Department: |
Responsibilities:• Analyzed finished products and raw materials by chemical and instrumental methods• Analyzed the above samples as per official as well as in house specifications • Recorded the analytical results in the company’s standard format • Extensively involved in other quality related activities such as Good Manufacturing Practices inspection, documentation and records management, preparation of SOPs and analytical development work • Coordinated with production, quarantine and dispatch sections to ensure the quality end product |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2003 to 2019 | Agency: CDSCO, Government Of India | Role: Regulatory Officer | Description: Reviewing Technical files |
Career Accomplishments
| Associations / Societies |
|---|
| 1.India Innovators Association 2. UKDCTN ( United Kingdome Dermatology Research Network 3. Indian Pharmacy Graduate Association 4. ISPE ( International Society for Pharmaceutical Engineering 5. Indian Pharmacy Graduates Association (IPGA) |
| Licenses / Certifications |
|---|
| Online Certification course from www, pharmaschool.uk Attended one day certification course in Cleaning Validation conducted by Seneca College, Canada |
| Professional Appointments |
|---|
| Nominated for policy implementations workshops conducted by WHO at Korea and China in 2013 and 2014 |
| Awards / Recognition |
|---|
| - Received Appreciation from the Drugs Controller General India for contribution in a court case of a disputed drug approval - Received Suggestion Scheme Award during tenure at M/S Wockhardt Pharmaceuticals |
Language Skills
| Language | Proficiency |
|---|---|
| English | Proficient |
| Hindi | Proficient |