We are pleased to announce that Aloka Srinivasan has accepted the position of Vice President, Regulatory Practice at Lachman Consultants, effective May 14, 2018.
Dr. Srinivasan is a recognized professional with more than 15 years of experience serving at FDA and National Cancer Institute where she contributed to: establishing a DMF review division in FDA to meet GDUFA related goals; the draft guidance for Type II API DMFs and writing QbRs for ANDAs and API’s. Dr. Srinivasan is well known for a series of articles regarding common deficiencies in ANDAs. Additionally, she is experienced in the assessment, reviewing and writing of ANDAs and NDAs with a focus on 505(b)(2) NDAs, INDs, DMFs, and FDA briefing documents for diverse therapeutic classes of drugs. She has worked with a broad range of dosage forms and drug products, evaluated CMC sections of applications, and performed scientific research.
Most recently, Dr. Srinivasan was Vice President, Regulatory Affairs at Lupin Inc.; prior to Lupin she worked for a CRO for four years. While at OGD/FDA for 9 years, her roles included: Team Leader/DMF Pilot Team; Team Leader/Division III; Senior Reviewer, Divisions I & III. Earlier in her career she was Senior Staff Scientist at the National Cancer Institute.
Dr. Srinivasan earned her Ph.D. in Chemistry from The University of Missouri at Columbia.
For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.