Global Quality Assurance & Compliance Consulting
Empowering pharmaceutical, biotech, and clinical research organizations to achieve regulatory excellence.
Quality Assurance Partners & Consultants
Empowering pharmaceutical, biotech, and clinical research organizations to achieve regulatory excellence.
About Quality Assurance Partners & Consultants
What Solutions Do We Offer at QAPC ?
We are a global consulting firm specializing in Quality Management Systems, Audits, and GxP advisory services. Our mission is to simplify regulatory complexity and help life sciences companies achieve compliance with confidence.
Service Solutions
⦁ Creation & Implementation of QMS Frameworks
⦁ SOP Development, Review, & Harmonization
⦁ Policy & Process Mapping
⦁ Data Integrity (ALCOA+) Programs
⦁ Controlled Document Management Systems
⦁ Development of KRIs & QTLs
⦁ Risk & QMS Performance Dashboards
⦁ ICH E6 & GCP Training
⦁ QA Strategy & Design (Risk-based)
⦁ Serious Breach Issue Review
⦁ Regulatory Submissions (NDA, BLA, MAA)
⦁ Compliance Gap Analysis Across Portfolio
⦁ GLP & GCP QA Integration for Early-phase R&D
⦁ Due Diligence QA Assessments (Licensing, M&A)
⦁ AI & Digital Tech Integration
⦁ QA Inspection Strategy for FDA, EMA, MHRA
⦁ Mock Bioresearch Monitoring (BIMO) Inspections
⦁ Inspection Management & Preparedness Checklists
⦁ Mock Interviews & Staff Training
⦁ On-site/Remote Inspection Support
⦁ Observation Response Support
⦁ Observation/Form 483 Response Drafting
General Audits
⦁ Process/ System audits
⦁ For-cause (directed) audits
⦁ Pre-inspection gap assessments
GCP Audits
⦁ Clinical investigator site audits
⦁ CRO/vendor audits
⦁ Trial Master File (TMF/eTMF) audits
⦁ Pharmacovigilance/safety audits
GLP Audits
⦁ Study audits (protocol adherence, raw data, final reports)
⦁ Facility audits (test sites, analytical labs)
⦁ Computerized system validation audits
- QMS Development – Build SOPs, CAPA systems, training, and gap assessments.
- Audits & Inspections – Site, vendor, process, and eTMF audits with detailed reporting.
- GxP Advisory – Inspection readiness, regulatory compliance, and issue management.
Our Services
Quality Management Systems (QMS)
Building robust quality systems for lasting compliance.
GxP Advisory & Compliance
Expert GxP guidance for seamless regulatory compliance.
Inspection Readiness
Preparing organizations for inspections through expert compliance guidance.
Audits Services
Audit readiness and inspection support you can rely on.
The Impact Our Research
At Quality Assurance Partners & Consultants, we drive measurable improvements in compliance, inspection readiness, and quality assurance. Our solutions empower clients to meet international regulatory standards with confidence.
Sample Analysis
Accurate sample testing ensuring compliance and data integrity for pharma.
.
Let's Explore Our Service Science Insights
Gain access to data-driven insights and proven strategies that help drive quality, compliance, and innovation across the life sciences sector.
DNA Sequencing
Reliable DNA sequencing services for research and genetic analysis.
Research Projects
Expert-led research solutions supporting pharma and biotech innovations.
Ecological Surveys
Comprehensive ecological surveys for regulatory and environmental assessments.
Analytical Testing
Validated analytical testing to meet international pharma quality standards.
Bioinformatics
Advanced bioinformatics tools for complex biological data interpretation.
Simple Step To Get Our Services
Follow these easy steps to connect and get started with our expert services.
- QMS Development
- Audits
- GxP Advisory
Identify Your Needs
Negotiations & Agreements
Payment & Administration
Get Evaluation & Feedback
Our Approach
Quality Management Systems (QMS)
GxP Advisory & Compliance
Audits Services
Inspection Readiness
Identify Your Needs
Define Agreement
Implementation
Evaluation
Sample Analysis
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus.
Sample Analysis
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus.
Sample Analysis
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus.
Sample Analysis
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus.
Sample Analysis
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus.
Track Our Journey
Why Choose US
Why Quality Assurance Partners & Consultants Stands Out. At QAPC , we are dedicated to providing exceptional service that prioritizes your needs. Our Approach combines our expertise in Quality Assurance systems with cutting edge solutions tailored to your unique pharmaceutical, biotechnology, and research needs.
- 15+ years of regulatory expertise
- 100+ successful audits worldwide
- Proven track record with pharma & biotech leaders
- Tailored solutions, not one-size-fits-all
Trusted by Clients Around the World
From emerging startups to global enterprises, our clients rely on our deep regulatory experience to deep experience in Quality Assurance to navigate complex compliance landscapes with confidence.
