Nikhil P.

Regulatory Affairs Executive at FDC Limited

Role: Executive at Fdc Limited
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

About Nikhil P.

I am a hardworking and energetic individual with good people skills who can adapt to any work related fields. i always try the best of myself for my career growth as an individuals well prophetically & personalize it myself sincerely

Experience

Executive
Fdc Limited
Feb 2021 — Present · Mumbai, IN
Preparation, compilation & submission of Original ANDA filling for US MarketSubmission of ANDA Dossier and post approval supplements CBE0, CBE30, PAS and Annual Report for US market and Type IA, Type IB and Type II for EU market with eCTD submission tool.Preparation and submission of Module 1 to Module 5 dossier sections.Review of Technical documents required for submissionsReview of Artwork/labeling as per the RLD products.Preparation of SPC, PIL and SPLRaise and review the change controls for different changes for US and EU markets Coordination with different dept for regulatory submissions

Education

Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon
Master of Pharmacy, Quality Assurance

Contact information

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Work email
•••••@fdcindia.com
Personal email
•••••@•••••.com
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Current company

Fdc Limited

Pharmaceutical Manufacturing · 4.8K employees · Mumbai, India

FDC carries forward the flaming spirit of it\'s first dream, achieving accreditations from the US-FDA, UK-MHRA, MCC-RSA, and the UAE, to cite a few. FDC is a forerunner in the manufacture of ORS and Ophthalmics, by setting up, globally approved, multi-location manufacturing facilities for Active Pharmaceuticals Ingredients (APIs) and Finished Dosage Forms. These facilities are located at Roha, Waluj and Sinnar in Maharashtra, Verna in Goa and Baddi in Himachal Pradesh. FDC has over 300 products and exports the same to over 50 countries, worldwide. FDC strives to explore, innovate and integrate solutions with modern technology, empowering talent and expanding healthcare horizons for a better quality of life to millions globally. Since 1936, FDC has been dedicated to innovating, manufacturing, and marketing high-quality healthcare products, in India, and abroad. FDC has over 300 products and exports to over 50 countries worldwide. People are our greatest strength, and it is our employees who make our company great. We are proud of our talented and committed employees and partners, who have consistently ensured that FDC continues to deliver world-class quality products and services. We have a long-standing heritage of commitment to excellence and innovation. These are attributes that have served us well through more than 80 years of growth, and they will continue to serve us in the future.

fdcindia.com

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About Nikhil P.

Experience

Executive

Education

Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon

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