End to End Regulatory Solutions & Capabilities

Regulatory Capabilities Overview

Full Scale Regulatory Solutions & Capabilities

With deep regulatory expertise and proven capabilities across global markets, we help companies navigate complex requirements with precision, efficiency, and compliance at every stage of the product lifecycle

Full Scale Regulatory Expertise and Solutions Coverage - Clinical Development to Post Approval Support

At Techsol Life Sciences, Our regulatory strategy is driven by a highly experienced team with deep-rooted expertise in global regulatory science and clinical development. Our leadership includes former U.S. FDA Regulatory Subject Matter Experts (SMEs) and senior regulatory professionals with nearly three decades of experience in regulatory affairs, drug development strategy, and Chemistry, Manufacturing, and Controls (CMC).

Our regulatory leadership has held key positions within the U.S. FDA, EU and the biopharmaceutical industry, contributing to the successful development and approval of products across multiple therapeutic areas. Their in-depth understanding of regulatory frameworks and evolving global requirements underscores Techsol’s commitment to compliance, regulatory excellence, and accelerated patient access to safe and effective therapies worldwide.

Key Achievements and Global Regulatory Impact

As part of Techsol’s regulatory leadership, Our Regulatory SMEs have, Led and contributed to over 100+ global regulatory approvals, including:

Marketing Authorizations

9 (BLAs and NDAs)

Biosimilar Approvals

in 2 emerging markets

Abbreviated New Drug Applications

23 (ANDAs)

Orphan Drug Designations

12 (ODDs)

7 Qualified Infectious Disease Product

(QIDP) Designations

55+ Investigational New Drug

(IND) submissions

Strategic Regulatory Engagements

Conducted over 100+ regulatory agency meetings, bringing strategic clarity and negotiation skills across multiple global markets:

Innovations in Regulatory Science

Our strategic leadership has directly shaped regulatory frameworks:

Highlights of Our Regulatory Team Accomplishments

Techsol’s regulatory team has a proven track record of resolving complex clinical hold issues, enabling the initiation of critical Phase 1 and Phase 3 trials across therapeutic areas including Cardiovascular, Antiviral, Vaccines, Ophthalmology, Oncology, Neurology: anti-migraine, anti-epileptic, Alzheimer’s, Parkinson’s, and antidepressants schizophrenia. Also, we have successfully submitted multiple INDs and Phase 2 protocols for start-ups and mid-sized companies, including novel delivery technologies like combination products, Cell Therapy, Gene Therapy, and Rare Diseases.

Expertise – Submissions, Agencies, Geo’s, Product Types & Tools

Introducing TOTALRegulatory - PV Function of the Future

TOTALRegulatory is a modern delivery framework enables sponsors to move beyond compliance toward proactive, efficient, and insight-driven safety monitoring ensuring patient safety remains at the heart of life sciences innovation.