About SteriQual

Specialized expertise in critical environment compliance.

Bridging complex global regulatory mandates with practical, science-backed facility validation and contamination control strategies.

16+ years hands-on
12 years in pharma equipment
USFDA, EMA, INVIMA
Ahmedabad, Gujarat

Grounded in science. Driven by regulatory excellence.

Founded in Ahmedabad, SteriQual Solutions Pvt. Ltd. was established to address the critical need for robust, technically sound compliance and contamination control strategies in high-precision industries. We bridge the gap between complex regulatory mandates and everyday laboratory operations.

With a foundation built on advanced postgraduate microbiology credentials and over 16 years of hands-on quality control and aseptic processing experience, we deliver precision-driven qualification, validation and contamination control strategies designed to ensure absolute regulatory alignment.

Our technical framework is backed by extensive, firsthand experience managing complex facility and system audits from leading global regulatory bodies, including the USFDA, EMA and INVIMA.

Beyond standard compliance support, we provide deep-dive technical expertise in microbial excursion investigations, operational deviations, aseptic processing simulation (APS) failures and out-of-specification (OOS) results, ensuring robust root-cause identification and CAPA implementation.

Company profileSteriQual Solutions Pvt. Ltd.
Based in
Ahmedabad, Gujarat, India
Areas of focus
  • Pharmaceutical and biopharmaceutical sectors
  • Semiconductor and microelectronics manufacturing
  • Controlled cleanroom environments
  • Sterile and depyrogenated consumables supply chain
Expertise
QC microbiology, aseptic processing, equipment and instrumentation compliance
Audits faced
USFDA EMA INVIMA
Talk to our team

Our vision

To be the most trusted quality partner for cleanrooms worldwide, known for simple compliance and accurate data.

  • Trusted quality partner
  • Simple compliance
  • Accurate data

Our mission

To protect product quality and patient safety by providing premium sterile supplies, clear facility qualifications, and fast expert solutions for contamination issues.

  • Premium sterile supplies
  • Clear facility qualifications
  • Fast contamination solutions

Our core values

The principles behind every protocol, investigation and report we deliver.

Leadership

Mehul Panchal

Principal Consultant

Experience
16+ years
Qualification
Postgraduate, Microbiology

Advanced postgraduate credentials in microbiology with over 16 years of core industrial experience in quality control microbiology and aseptic processing techniques. A proven track record managing regulatory audits from the USFDA, EMA and INVIMA, with specialized expertise in resolving microbial excursions, deviations, APS failures and OOS results.

  • Microbial excursions
  • Deviations
  • APS failures
  • OOS results

Dharmesh Prajapati

Consultant, Instrumentation & Equipment Compliance

Experience
12 years
Qualification
B.E. Instrumentation

A B.E. in Instrumentation with 12 years of specialized engineering experience focused on pharmaceutical industry equipment. Provides expert oversight for hardware qualification, automation validation and instrument calibration alignment, so your critical systems fit modern production requirements.

  • Hardware qualification
  • Automation validation
  • Instrument calibration

Experience that stands up in an inspection

SteriQual Solutions brings over 16 years of hands-on expertise in pharmaceutical microbiology to deliver precision-driven, tailored compliance solutions.

Our team specializes in developing risk-based environmental monitoring programs and robust contamination control strategies (CCS). By combining this scientific insight with 12 years of core instrumentation engineering experience under our leadership, we bridge the gap between complex equipment qualification, computer systems validation (CSV) and plant operations.

Our technical frameworks are built to withstand strict international standards, backed by a proven track record of directly facing and successfully defending facilities during rigorous global audits.

Ready to build an audit-ready system?

Let’s talk about your project and find the perfect solution for your facility.

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About Us | SteriQual Solutions