Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.
Proficient in testing raw materials, finished products, and stability samples for Nasal formulations. Knowledge of method validation, calibration, and qualification activities.
MS in Pharmaceutical Analysis/Post Graduation in Pharma. analyse product strategy, efficiency, and cross-functional issues in Analytical Research and Development. Dr. Reddys Laboratories
To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form based on QbD approach. To execute the experiments as per Design of experiments
CORONA Remedies Pvt. Ltd. Our journey started in 2004, with a commitment to creating a better quality of health for all by being at the forefront of research, manufacturing and marketing of high quality products.
Establish and lead the downstream group within the Biological Drug Substance Unit with process and operations-based expertise to support delivery of developed purification processes and of clinical batches of purified recombinant proteins
Literature review for product development for US/ EU/ ROW market especially complex injectable’s like Liposomes, Nanoparticle suspension, Microspheres, Suspension’s, Emulsion’s, Lyophilized products, Peptide Injectable’s, Drug delivery systems.