Udavant -  - Mumbai, Maharashtra, India

Mrunalini Udavant

Mumbai, Maharashtra, India

Work History

Indian Merchants Chamber

From January 2009

DIA

NEW DRUG DEVELOPMENT, REGISTRATION AND APPROVAL- KMK COLLEGE OF PHARMACY

REGULATORY GUIDELINES

From January 2007

Assistant Manager Regulatory Affairs

Meyer Organics Pvt. Ltd

May 2004 - April 2014

Executive in packaging Development Dept

Meyer Organics Pvt. Ltd

Organization- Meyer Organics Pvt. Ltd. Thane - 400 604

Executive in production Dept

Meyer Organics Pvt. Ltd

From July 1998

PRODUCTS HANDLED:-
Multivitamin and Multimineral products in Drug category as well as in Dietary supplement category (Tablets, Capsules and Liquid, Injectables, I.Vs), Calcium Supplement products, Vitamin C and Vitamin D like single ingredient products, Infertility Supplement, etc

Anti-infective, Antacids, Muscle Relaxants, Analgesics, Anti-cold Preparations, cough Preparations, etc.

JOB PROFILE
• Preparation and checking of legal documents like applications to FDA for product permission, FSC, COPP, Health Certificates, DCGI permissions for formulations, neutral code, labeling, etc.
• Preparing/ checking and submitting technical files and compilation of dossiers in CTD format as required for semi regulated countries such as Philippines, Cambodia, Vietnam, Kenya, Nigeria, Ghana, Guatemala, Salvador
• Handling product registration in countries like Myanmar, Trinidad & Tobago, Yemen,
Sri Lanka, Guyana, Zambia, Sierra Leone, Botswana, Syria, Uganda, Tanzania, Indonesia, Iran, U.A.E., Cameroon, Mauritius, Madagascar, Mozambique, Hong Kong, etc.
• Ensuring Effective and Prompt Attention and Handling of Queries from MOH of various Countries.
• Review of technical documents for dossier compilation.
• Review follow-up and co-ordination for registration samples /WS and impurities required for analysis purpose
• Preparation of Data required for Artwork & subsequent checking
• Co-ordination for Bioequivalence Studies and Comparative Dissolution data as per requirement.

SEMINAR ATTENDED

Assistant Manager Regulatory Affairs

MARKSANS PHARMA LIMITED

Joined since April 2014

Qualifications & Certifications

Biochemistry. Ahmed Nagar

Higher secondary class

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