About Paul T. Sudhakar

Over 30 years of experience in the pharmaceutical and related industries

Paul T. Sudhakar, M.B.A., brings over 30 years of extensive expertise in the pharmaceutical and related industries as Owner, President, and CEO of PTS Consulting LLC. Throughout his career, Mr. Sudhakar has been deeply immersed in product development endeavors, encompassing a wide spectrum of regulatory support activities. His proficiency includes, but is not limited to, guiding preclinical and clinical trials, overseeing bioequivalence studies, ensuring compliance with chemistry and manufacturing controls, and navigating the intricate process of filing and obtaining approvals for drug applications.

Moreover, Mr. Sudhakar has played a pivotal role in managing FDA review processes for drug, biologic, and medical device applications, demonstrating a keen understanding of regulatory requirements. His experience extends across diverse pharmaceutical formulations, including transdermal/topical, extended-release, immediate-release combination, and injectable dosage forms, as well as biotechnology. With his comprehensive skill set and industry insight, Mr. Sudhakar continues to drive successful regulatory, approval, and launch initiatives for pharmaceutical products, positioning PTS Consulting LLC as a trusted leader in the field.

Pharamacutical Consulting


NDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)


Filing & Managing all of the Processes for FDA Drug Applications


FDA and Global Regulatory Compliance and Submission


Complete Facilities Design from inception to full FDA qualification


We’re involved in the forefront of product development, analytical testing, manufacturing and clinical & pharmacokinetic testing of high quality off-patent pharmaceuticals. PTS consults on investigational research in a clinical trial using the patient’s own stem cells to assess the efficacy and safety for patients with advanced Critical Limb Ischemia.

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