Nidhi Aghera

Prepare, review, and submit dossiers in CTD/ACTD formats or according to country-specific guidelines (Myanmar, Cambodia, Honduras, Guatemala, Nicaragua, El Salvador, Philippines, Moldova). Handle regulatory queries from clients and regulatory authorities with detailed technical justifications. Review product artworks and labeling to ensure compliance with regional regulatory requirements.

Specialized in pharmaceutical regulations, drug approval processes, and international guidelines (ICH, USFDA, EMA, WHO, ROW markets). Studied in-depth regulatory documentation, dossier preparation (CTD/eCTD), labeling requirements, and post-approval activities. Thesis: Regulatory Perspective of B

Gained strong foundation in Pharmaceutical Sciences, including Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, and Pharmacognosy. Hands-on training in laboratory techniques, quality testing, and documentation practices as per industry standards. Participated in seminars and workshops on dr