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Blog Author

Dr. Padmini Karnatham, M.Pharm., Ph.D.

Specialization: Medical & Regulatory Writing | Scientific Communications
LinkedIn: linkedin.com/in/padmini-karnatham

About

Dr. Padmini Karnatham is a Medical and Regulatory Writer with over 11 years of combined experience in academia and scientific communications. 

She has developed regulatory and clinical documents aligned with ICH, FDA, and EMA standards and has supported pharmacovigilance and publication writing projects across multiple therapeutic areas.

Her portfolio includes more than 35 clinical and scientific write-ups and 14 publications in peer-reviewed journals.

Education

  • Ph.D. (Pharmaceutical Sciences) – Sri Padmavati Mahila Visvavidyalayam, Tirupati (2024)

  • M.Pharm (Pharmaceutical Chemistry) – 2012 | 81%

  •  B.Pharm – 2009 | 82% | University First Rank | Gold Medalist

Professional Experience

Freelance Medical Writer (2022 – Present)

  • Developed 20+ regulatory and scientific documents (SPC, PIL, CSR, IB).

  • Created clinical manuscripts, abstracts, and slide decks for various therapeutic domains.

  • Edited regulatory submissions and supported publication projects.

Assistant Professor – Pharmaceutical Chemistry

Sree Vidyanikethan College of Pharmacy, Tirupati (2013 – 2021)

  • Taught UG/PG pharmacy courses with a focus on scientific writing and mentorship.

  • Guided 30+ student projects and facilitated multiple publications.
    Developed academic content and e-learning modules.

Key Competencies

  • Regulatory & Scientific Writing (SPC, PIL, CSR, IB)

  • Pharmacovigilance & Safety Narrative Writing

  • Publication Support and Proofreading

  • Clinical Trial Summaries (IND/NDA Modules)

  • Literature Review and Referencing (EndNote, Mendeley)

  • Compliance with ICH-GCP, FDA, and EMA Guidelines

Highlights

  • Authored and co-authored 14 papers in Scopus-indexed journals.

  • Produced 35+ clinical and regulatory documents across therapeutic categories.

  • Registered Pharmacist, Andhra Pradesh State Pharmacy Council (Reg. No. 62263/A1, 2010).

 

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