"Our Team Leaders in Quality. Champions of Compliance."

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SK Dhumal – Founder & Principal Consultant With over 30 years of experience in the biopharmaceutical and pharmaceutical industries, SK Dhumal is a recognized expert in GxP quality systems, regulatory compliance, audits, and training. He has led global efforts to help companies produce high quality medicines and secure regulatory approvals.

 

Throughout his career, he has:

• Conducted 250+ audits and gap assessments globally.

• Pioneered cGxP quality standards and compliance culture initiatives

• Led remediation programs post-regulatory enforcement.

• Implemented digital quality systems, including eQMS, LIMS, eLAB, and SAP.

• Worked across sterile and non-sterile dosage forms.

• Provided high-impact auditing and technical training.

 

Previous Leadership Roles:

Pfizer | Hospira | Lupin | Strides | Wockhardt Biotech | Shilpa Biologicals

 

Education & Certifications:

• Postgraduate in Microbiology

• Diplomas in Pharmacy and Regulatory Affairs

• Certified ISO Lead Auditor

• Qualified GMP Trainer

 

Career Highlights:

• Led major global compliance projects across regulated markets.

• Successfully managed inspection readiness and audit programs

• Developed quality strategies with a focus on patient safety and regulatory alignment.

• Known for building high-performing quality teams and delivering results.

 

Core Values

• Regulatory Compliance

• Operational Efficiency

• Ethical Integrity

• Customized, Value-Driven Solutions

• Long-Term Quality Partnerships

“Your Trust is Our Endowment!”

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“We assess your business risks and address them to your complete satisfaction, aligned with evolving regulatory expectations. Our decisions always prioritize patient safety, and our identity is grounded in ethics and business integrity.”

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Our Expert Network

Our consulting team includes seasoned professionals with backgrounds in top-tier, regulated pharma and biopharma companies.

We offer a unique combination of industry and consulting expertise, supported by: Professionals with deep knowledge in:

• QMS setup and optimization

• Qualification & validation (equipment, process, cleaning, computer systems

• Sterility assurance & microbiology

• Quality Control & data integrity

• Engineering & facility compliance

 

Trainers with excellent technical, communication, and demonstration skills Personnel who uphold the highest standards of ethics and integrity Accelerating Compliance Culture Across the Life Sciences Industry Q-Exel GxP is your partner for strategic GxP consulting across auditing, gap assessments, remediation, digital transformation, and workforce capability building—serving pharmaceutical and biopharmaceutical clients globally.