F&D

Review documents required for regulatory submissions across global markets, including product development reports and scientific justifications for responding to regulatory queries.

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

Hands-on expertise in HPLC, UPLC and dissolution testing. Knowledge of ICH, USP, and other international guidelines.

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.

Planning and Execution of Lab scale experiments. DOE, Quality by Design, Product Development, Stability Protocol, Regulatory Market.

PHARMACY GRADUATE WITH 3 TO 7 YEARS OF EXPERIENCE IN FORMULATION DEVELOPMENT OF STERILE DOSAGE FORMS AS PER GUIDELINES OF US, EU, CANADA, BRAZIL AND ROW MARKET.

Lab experience for Analytical Method Development, regular and stability sample analysis. Handling of HPLC for Assay, Dissolution, Related substances tests for solid orals.