To Review, check the method validations data as per the USP 1225– Validation of Compendial methods, ICH-Q2 guidelines for validation of analytical procedures, ANVISA, ORA-LAB, SOP and method of analysis.
Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world
Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and reguiations.API Equipment Handling.
MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required.
M.Sc in Life Science / M.Pharm from recognized University or Equivalent with NET/GATE qualified. National Institute for Interdisciplinary Science and Technology
Post Graduate in Life Sciences, Microbiology, Biotechnology, Biochemistry. NET / GATE qualification or any national eligibility test is mandatory. Institute of Liver and Biliary Sciences ILBS is a tertiary care, super-specialty hospital
B.Sc., M.Sc., B.Pharm, M.Pharm; Cliantha QC Lab Reviewer and QA Lab Auditor. Research QC ensures compliance with regulatory standards by maintaining the quality of data for both small and large molecule bioanalytical laboratories.
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.
LENZ Therapeutics, Inc announced the US Food and Drug Administration approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025. Direct-to-eye care professional sales and marketing activities to be initiated immediately.
AbbVie announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 83.8 (approximately 16% scalp hair coverage).