YOUR TRUSTED PARTNERS WHEN QUALITY MATTERS
About us
SISPQ Inc. is a global consulting firm committed to delivering regulatory, quality, validation, audit compliance and engineering solutions for the life sciences industry. Our name stands for Safety, Identity, Strength, Purity, and Quality, which reflects the foundation of our work and values. Our guiding principle is embedded in our slogan “When Quality Matters.” This is more than just a tagline; it represents our unwavering commitment to building pharmaceutical systems, facilities, and documentation that prioritize patient safety, regulatory compliance, and product excellence. We understand that in the life sciences industry, quality is not negotiable — it is foundational. Our work is designed to ensure that every process, every document, and every outcome stands up to the highest global standards.
Vision
Our vision is to be a trusted partner in the pharmaceutical industry by delivering exceptional medical writing and pharmacovigilance services rooted in the principles of Safety, Identity, Strength, Purity, and Quality (SISPQ). We are dedicated to enhancing patient safety and ensuring the highest standards of data integrity and regulatory compliance. Through our commitment to excellence, accuracy, and transparency, we strive to support our clients in advancing healthcare outcomes and maintaining the utmost quality in every aspect of their products and processes.
Services
Process, Cleaning, and Method Validation
- Process Validation Master Plan and Protocols (Stage 1-3 lifecycle)
- Cleaning Validation risk matrix and residue limits determination
- Drafting and execution of Cleaning Validation Protocols and Reports
- Analytical Method Validation protocols and results interpretation
- Establishing a Continued Process Verification (CPV) strategy
- Sampling plans and methodology for validation data
Combining scientific expertise with editorial precision, we create clear, concise, and regulatory-compliant documents to support your drug development process.
Audit Readiness and Regulatory Support, Project Management & Reporting, and Periodic Review & Requalification
From designing internal audit programs to simulating full-scale WHO/US FDA inspections, we help you prepare every step of the way. Our experts support document room setup, CAPA tracking, and training your team for successful audit outcomes.
Lifecycle Validation & Regulatory Compliance
We design and implement lifecycle frameworks for validation and QMS, including requalification protocols for HVAC, WFI, Purified Water, and more. Stay compliant with periodic reviews of CSV/DI systems, SOPs, deviations, and change controls—backed by a comprehensive compliance calendar.Project Management Excellence
Your success is our mission. We provide detailed project plans, milestone tracking, Gantt charts, risk/issue logs, and performance dashboards. Our resource utilization tools and regular leadership reviews ensure every initiative is delivered with transparency and efficiency.
Keep in Touch!
Contact us today to learn how we can support your quality needs throughout the drug development process.
225 Dyer StProvidence,
RI 02903, USA
1270 Fischer-Hallman
Rd UNIT B3 & B4, Kitchener,
ON N2R 1P7
1023, Maple Trade
Ctr RdMemnagar, Ahmedabad,
Gujarat 380052, India