Mitigate risks and stay compliant.
- Time-effective: Time-effective: Speed up processes with our experienced CQV consultants.
- Reduce Compliance-related Risks, and adapt quickly with our quality expertise, aligned with FDA, EMA, MHRA, PIC/s, ANVISA, WHO, and other regulatory authorities.
- Minimize costs: Skilled in adapting to diverse client quality systems, policies, and procedures, we deliver cost-effective tailored solutions for your needs.
No More Business Disruptions and Project Delays
Operating in a fast-paced and highly regulated industry presents unique challenges that can impact your company’s operations and reputation.
Our CQV team does all the heavy lifting for you ensuring compliance and safeguarding you against against delays and operational inefficiencies are addressed.
We aim to provide tailored solutions to ensure compliance, efficiency, and reliability, enabling your growth.
Lost in the complexities of regulatory compliance
Production halts due to cGMP non-compliance
Loss of reputation and clients
Project delays and high CQV costs
Remove the Guesswork:
Try Our Expert-Led Dynamic Approach to Compliance
Teknokrat always put clients first and guide them through the complexities of regulatory compliance and the production of high-quality products that save and improve lives.
Our dedicated experts are ready to step in and offer strategic advice, meticulous risk management, and innovative solutions to ensure your projects meet regulatory standards.
- Validation Plan (VP) / Validation Master Plan (VMP)
- Commissioning Plan
- Process Equipment and Utilities Inventory
- User Requirement Specifications (URS)
- Functional Specification (FS) and Design Specification (DS) Review
- Design Qualification (DQ) and Design Review (DR)
- Risk Analysis (RA) / Impact Assessment (IA)
- Supplier Testing Activities Support (FAT/SAT)
- Qualification Protocols (IQ, OQ and PQ) preparation and execution:
- Process Equipment, Clean Utilities (water system and process gasses) and HVAC & Clean Room Qualification
- Periodic Requalification
- Decommissioning
- Transport Validation
- Technology Transfer
- Qualification Procedure
- Maintenance and Calibration Procedures
- Temperature Mapping
- Sterilization Process Validation
- Periodical Requalification
- Periodic Review
- Calibration Service
- GMP Compliance Assessment
- Inspection Readiness Assessment
- GAP Analysis and Remediation Plan
Pioneering Innovation and Unwavering Dedication
to Life Science for Over a Quarter Century
We are at the forefront of innovation, breathing life into every project we touch and transforming ideas into real-life solutions that contribute to your success and the well-being of your customers and patients.
Proven track record of
Industry excellence
With decades of unparalleled service and more than 15k executed projects, PQE Group stands as a beacon of excellence, consistently delivering innovative, tailor-made solutions to Life Science players of all sizes.
Global coverage,
local impact
Benefit from our diverse team and a global footprint spanning across 40+ offices, accessing multicultural perspectives and international expertise to address your unique needs and drive success at the local level.
Unmatched comprehensive support,
training & expertise
We believe in empowering our clients with comprehensive support and training programs designed to elevate expertise at every level. Our approach ensures that clients not only receive cutting-edge solutions but also the knowledge and skills to sustain excellence.
Tailor-made solutions
for any challenge
We pride ourselves on not just offering solutions but crafting customized strategies that fit the unique needs of each client. Our flexible approach is far from one-size-fits-all; it’s about understanding the specifics of your challenge and responding with agility and precision.
Comprehensive CQV Services Across 4-Key Areas
With thousands of successful projects completed and counting, our CQV services encompass a comprehensive range of offerings.
From handling your Equipment Validation, ensuring your tools are both reliable and compliant, to providing Clean Utilities services for maintaining the purity and efficiency of your utility systems, along with environmental control optimization and calibration services to ensure the accuracy of your instrumentation, we deliver a seamless and integrated approach to meet your Commissioning, Qualification and Validation needs.
Equipment Validation
Ensure optimum performance, safety, and compliance with our tailored equipment validation services for both sterile and non-sterile processes, covering a wide array of equipment.
Clean Utilities
Tailored validation and compliance services for Clean Utility Systems, including for WFI, Purified Water (PW), Pure Steam (PS), Compressed Air, and Nitrogen systems.
Temperature Mapping
Get thorough analysis & validation for critical environments in pharmaceutical, biotech, & healthcare sectors with our Thermal Mapping Service.
Instrument Calibration
Ensure tool accuracy, reliability, & compliance with our Instrument Calibration Service on your site with specific procedures or through SOPs with an advanced instrument park.