Life Therapeutics Private Limited
Life Therapeutics
Life Therapeutics regulatory consulting service is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals, medical devices, chemicals and food contact notifications (FCNs). Founded by Dr. Krishnamurthy, who is a Ph.D., in Clinical Immunology and Genetics and MBA from Georgetown University, previously served for more than 29 years working in Academia, Department of Defense, Food and Drug Administration (FDA) and Medical Device, Pharmaceuticals, Biologics and Chemical industry and became as the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective products to market within the U.S.
Life Therapeutics regulatory consulting was founded on the premise that biotechnology, medical devices, pharmaceuticals, Chemicals and Food Contact Substances hold the promise of a better future for everyone – making good on that promise requires innovative approaches, world-class science, regulatory know-how and a team dedicated to bringing all of it together. We believe open communication and transparency are the foundation of a successful outcome for your new product. It’s our obligation to provide an honest assessment, realistic timelines, credible science, accurate submissions and an effective regulatory strategy to our clients. We take pride in delivering innovative solutions and extraordinary results for clients across the globe – and we know those results are a direct result of the care and commitment we bring to each client engagement.
Life Therapeutics regulatory consulting service assisting clients all over the globe to address nonclinical, clinical, product development, and regulatory compliance challenges. In the past three years, we have served clients across the globe; we have contributed to original Pre-IND, INDs, BLAs/NDAs, generic drug ANDAs, Drug Master File (DMF), Medical Device Master File (MAF); Medical device Pre-Sub/Q-Subs, 510(k)s, 513(g), De Novo, IDEs and PMA submissions, Pre-meeting and Food Contact Notifications (FCNs).
The cornerstone of this success is found in our team of consultants and staff, comprising subject-matter experts with decades of industry and/or FDA experience. It is this experience that allows us to provide an unparalleled "insider" perspective on how best to navigate your new product from discovery through testing, nonclinical work, clinical trials, regulatory approvals, and ultimately arrive at market in the most efficient manner.
Regardless of the stage of your product's development, Life Therapeutics regulatory consulting service has the insight and experience necessary to help you overcome the next set of challenges and bring your product to market in the most responsible and efficient manner possible. With a team of experts and an unmatched track record of achievement in both regulatory approval and product development consulting, rest assured that with Life Therapeutics Regulatory Consulting on your side, you are in the best possible position for a successful outcome for your medical devices, pharmaceuticals, biologics, chemicals and food contact substance approval from FDA.
