Swapn Shejwal

Interest in Solving problems in finance, math, Chemistry, Biology, and Pharmacy, Online tutoring

Teaches Cost Accounting

Newly Joined

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About Swapn

I am a postgraduate in Pharmacy (M. Pharma) with a strong academic background in Pharmacology, Pharmaceutics, and Pharmaceutical Chemistry, finance related issue. I am passionate about education and have experience in solving academic questions for students in a clear, step-by-step manner.

I have worked on various academic platforms and am skilled at providing accurate, plagiarism-free, and well-structured solutions in subjects like Chemistry, Biology, Anatomy, Physiology, and Medical Sciences. I focus on conceptual clarity and aim to simplify complex topics for better student understanding.

I am committed to delivering high-quality academic assistance while meeting deadlines and maintaining academic integrity. I am confident that my subject expertise and dedication to quality will contribute positively to the SolutionInn platform and its student community.
I have work on Chegg solution India
Transtutor,
study.com
brainly,
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Skills

Advanced-management-accounting Algebra Anatomy Applied Mathematics Calculus Cost Accounting Econometric Mathematical-chemistry Organic Chemistry Pharmacy

Resume

2024 — Present

Dr. Babasaheb Ambedkar Technological University

Masters in M Pahrmacy

British Indian Ocean Territory

2024 — Present

Lupin Limited

Regulatory Submissions:

Prepare, compile, and review ANDA, NDA, DMF, and supplements for USFDA submission.

Ensure all documents meet eCTD structure and formatting requirements.

Submit and manage responses to USFDA queries (Information Requests, Complete Response Letters).

Regulatory Strategy:

Support development of regulatory strategies for new products and lifecycle management of approved products.

Monitor regulatory changes and ensure timely updates to the internal teams.

Documentation and Compliance:

Coordinate with cross-functional teams (R&D, QC, QA, Production) to gather data and documents.

Ensure all documents comply with 21 CFR regulations, ICH guidelines, and USFDA requirements.

Maintain up-to-date regulatory dossiers and submission archives.

Labeling and Artwork Review:

Review and ensure compliance of product labels, inserts, and packaging with USFDA regulations (21 CFR Part 201).

Communication & Liaison:

Liaise with US agents, contract manufacturers, and consultants regarding regulatory submissions and updates.

Coordinate with legal and intellectual property teams for product exclusivity and patent information.

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