CLINICAL RESEARCH LEADER

Driving Operational Excellence in Clinical Research

Head of Bioavailability & Bioequivalence | 25+ Years Experience | Expert in BA/BE, Regulatory Inspections (USFDA, EMEA), and Global CRO Operations.

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25+
Years Exp
60+
Approvals
300+
Inspections
30k+
Studies
Manoj Shukla

Manoj Shukla

M.Sc, MICA | Biopharmaceutical Expert

Hyderabad, India

About Me

Strategic Scientific Leader & Operational Expert

I am the Head of Bioavailability & Bioequivalence Department at Vimta Labs Ltd. With over two decades of robust experience in the pharmaceutical and CRO sectors, I am a recognized authority in biopharmaceutical, bioanalytical, and clinical research management.

My expertise spans the entire spectrum of clinical operations—from designing global biopharmaceutics strategies and managing complex regulatory inspections (USFDA, WHO, EMEA, ANVISA) to driving revenue growth and operational efficiency. I have successfully led over 300 client audits and numerous high-stakes regulatory inspections, maintaining a reputation for problem-solving and quality compliance.

Known for mentoring teams and driving innovation, I combine deep scientific knowledge with strategic business acumen, having previously built and scaled full-service CRO operations in India and Canada.

Core Expertise

Delivering successful outcomes across Phase I–IV clinical trials

Regulatory Strategy

Expert in global biopharmaceutics strategies including ADME, PK/PD modeling, and Biowaivers.

  • USFDA, EMA, PMDA & ANVISA Liaison
  • 60+ Regulatory Approvals
  • Complex Regulatory Responses

CRO Leadership & Growth

Building and scaling full-service CROs with focus on revenue and EBITDA.

  • Managed ₹300+ Cr Revenue
  • Strategic Client Engagement
  • Optimized Resource Planning

Scientific Operations

Deep technical expertise in bioanalytical and clinical lab capabilities.

  • 2,500+ Complex Methods Developed
  • Injectables, Inhalers & Biosimilars
  • LIMS & eCRF Implementation

Professional Journey

A track record of leadership in global clinical research

Mar 2023 - Present
Head Clinical Research (BA/BE & CT)
Vimta Labs Ltd

Leading overall operations for clinical research facilities, project management, and regulatory functions in Hyderabad.

Previous Role
Vice President of Operations
Panexcell Clinical Lab

Devised and deployed processes to boost long-term business success. Monitored strategic level operations and business processes.

Previous Role
Head of Bioanalytical
Lambda Therapeutic Research

Led bioanalytical operations in Ahmedabad, India and Toronto, Canada. Managed cross-functional teams and international compliance.

Previous Role
Department Head
Veeda Clinical Research

Responsible for overall operations of BA/BE clinical research facilities and successfully leading numerous regulatory inspections.

Education

Master in Instrumentation & Chemical Analysis (MICA)

Jiwaji University, Gwalior

Master of Science (M.Sc)

Jiwaji University, Gwalior

Key Achievements

  • Led 50+ International Regulatory Inspections (USFDA, MHRA, ANVISA, etc.) with multiple zero-observation audits.
  • Delivered 30,000+ clinical studies including FIM, BA/BE, and complex PK studies.
  • Set up clinical lab capabilities for injectables, inhalers, glucose clamps, TDS, and monoclonals.
  • Numerous international publications and scientific posters presented at global conferences.

Get in Touch

Interested in collaboration or consulting regarding Clinical Research, Bioequivalence, or Regulatory Strategy?