Strategic GxP Auditing
Qualification, routine, and for-cause audits of CDMOs, CROs, specialty pharmacies, clinical sites (Phases 1–3), and GxP vendors, data systems, and technology platforms — risk-based, regulatory-grade, and fully documented.
Enhancing GxP Compliance Across
Pharmaceutical and Biotech —
From Discovery to Commercial Launch.
QTech Solutions delivers expert, independent GxP quality management and regulatory compliance consulting — spanning strategic auditing, internal process assessments, data integrity, CSV, and QMS remediation.
GxP+
Full-Spectrum
100%
Independent
Comprehensive GxP consulting across the full product lifecycle
Independent, risk-based expertise spanning regulatory strategy, global audit programs, internal process audits, data integrity, and quality system transformation — delivered by a senior SME on every engagement.
Internal Process Audits
Independent internal GxP process audits to ensure your quality systems, SOPs, workflows, and controls remain compliant and inspection-ready — before a regulator or sponsor auditor finds the gaps.
CSV & Advanced Technology
Expert auditing of computer system validations, SaMD, SaaS platforms, AI/ML tools, and eClinical systems per GAMP 5, IEC 62304, and 21 CFR Part 11.
Clinical & Laboratory Auditing
GCP auditing of CROs and investigator sites. GLP/GCLP qualification of toxicology facilities, bioanalytical labs, and central labs — with deep expertise in sample management and BIMO readiness.
Data Integrity & 21 CFR Part 11
ALCOA++ compliance assessments, electronic records and signatures reviews, IT security, disaster recovery, GDPR, and HIPAA auditing — ensuring robust data lifecycle management across regulated systems.
QMS Remediation & Development
Expert QMS development for emerging biotechs, CAPA optimization, change control, and deviation management — building systems that scale without generating unnecessary overhead.
Global regulatory coverage across every GxP discipline
QTech Solutions operates across the full international regulatory landscape — US, EU, UK, Canada, Japan, Brazil, and China — applying the precise framework that governs your program, your region, and your product type.
Good Manufacturing Practice — GMP
United States
21 CFR Parts 210 & 211 (Finished Pharmaceuticals) · 21 CFR Part 820 / QSR (Medical Devices) · 21 CFR Part 600 (Biologics)
European Union
EudraLex Volume 4 (GMP Guidelines) · EU Annex 11 (Computerised Systems) · EMA Guidelines · EU MDR 2017/745
International / ICH
ICH Q7 (APIs) · ICH Q8 (Pharmaceutical Development) · ICH Q9(R1) (Quality Risk Management) · ICH Q10 (Pharmaceutical Quality System) · PIC/S GMP Guidelines
Canada
Health Canada GUI-0001 (GMP for Drug Products) · Food and Drugs Act Regulations C.02 · MDSAP
Japan
PMDA / MHLW GMP Ordinance No. 179 · Japan GMP Guidelines · PMDA inspection standards
Brazil
ANVISA RDC 301/2019 (GMP for Drug Products) · ANVISA RDC 204/2017 (APIs) · ANVISA GMP certifications
China
NMPA GMP (2010 revision) · CFDI inspection standards · China GMP Certificate requirements
GCP · GLP · GCLP · GDP · GPvP
Good Clinical Practice — GCP
ICH E6(R2) & E6(R3) · FDA 21 CFR Parts 50, 56, 312, 314 · EU Clinical Trials Regulation No 536/2014 · Health Canada GCP Guidelines · NMPA GCP (China) · MHLW GCP Ordinance No. 28 (Japan)
Good Laboratory Practice — GLP
FDA 21 CFR Part 58 · OECD Principles of GLP (Series 1) · OECD Advisory Document No. 22 (Data Integrity) · EU Directive 2004/10/EC · Japan GLP Standards (MHLW) · NMPA GLP (China)
Good Clinical Laboratory Practice — GCLP
WHO GCLP Guidelines · CLIA (US) · CAP Accreditation · EMA Bioanalytical Method Validation Guidance · FDA BMV Guidance (2018) · ICH M10 (Bioanalytical Method Validation)
Good Distribution Practice — GDP
EU GDP Guidelines (2013/C 68/01) · WHO GDP Guidelines · FDA 21 CFR Part 211 Subpart H · DSCSA (Drug Supply Chain Security Act) · Health Canada GDP Requirements
Good Pharmacovigilance Practice — GPvP
EU GVP Modules I–XVI (EMA) · FDA 21 CFR Part 314.81 / 21 CFR Part 600.80 · ICH E2A–E2F Safety Reporting Guidelines · Health Canada Vigilance Reporting Requirements · PMDA Safety Reporting (Japan)
SDLC · Data Integrity · Advanced Technology
Software & System Validation — SDLC
GAMP 5 (ISPE) · FDA 21 CFR Part 11 (Electronic Records & Signatures) · EU Annex 11 · IEC 62304 (Medical Device Software Lifecycle) · FDA Guidance on Computer Software Assurance (CSA 2022) · ISO 13485:2016 (Clause 7.3 Software Development)
Data Integrity — Global Requirements
ALCOA++ Principles · FDA Data Integrity Guidance (2018) · MHRA GxP Data Integrity Guidance (2018) · WHO Data Integrity Guidance (TRS 996, Annex 5) · EMA Data Integrity Q&A (2016) · OECD Advisory Document No. 22 on GLP Data Integrity · PIC/S PI 041-1 (GMP Data Integrity)
SaMD, AI/ML & Digital Health
FDA SaMD Guidance · FDA AI/ML Action Plan & PCCP Framework · ISO 13485 / IEC 62304 (SaMD lifecycle) · EU AI Act (Medical Application provisions) · FDA Companion Diagnostic Device Guidance
IT Security & Infrastructure
SOC 2 Type II · ISO 27001 (Information Security) · FDA Cybersecurity Guidance (Medical Devices, 2023) · HIPAA Security Rule · GDPR (EU) 2016/679 · Business Continuity & Disaster Recovery (BCDR)
Device & Combination Product Standards
ISO 13485:2016 · ISO 14971:2019 (Risk Management) · EU MDR 2017/745 · EU IVDR 2017/746 · FDA 21 CFR Part 820 / QSR · MDSAP · NMPA Medical Device GMP (China)
Independent expertise.
Proven across the full GxP spectrum.
QTech Solutions is not a generalist consulting practice. It is a focused, senior-led audit firm with a documented record of executing regulatory-grade GxP audits across every major regulated domain — GMP manufacturing and CDMO qualification, GLP nonclinical toxicology, GCLP bioanalytical and central laboratory operations, GCP clinical investigator sites, SaMD and AI/ML platform qualification, and internal GLP sponsor oversight programs. Every engagement is led by a principal auditor with direct, hands-on experience conducting the type of audit your program requires.
This breadth is not claimed — it is evidenced by executed, signed audit reports delivered to major pharmaceutical and biotechnology sponsors for their most regulated and high-stakes programs. When you engage QTech, you receive the same caliber of senior independent expertise that leading drug developers depend on when regulatory defensibility is non-negotiable.
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Truly Independent Perspective
No vendor relationships, no product sponsorships, no conflicts of interest. Our assessments reflect the genuine state of your compliance posture — because honest findings are what protect your program and your patients.
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Senior SME on Every Engagement
You work directly with the expert — not a project manager overseeing junior consultants. Real expertise, applied to your specific regulatory and operational challenges, every time.
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Cross-Spectrum GxP Depth
GMP CDMOs. GLP toxicology facilities. GCLP bioanalytical labs. GCP investigator sites. SaMD/AI-ML platforms. Internal systems audits. Very few independent consultants bring genuine expertise across all of these — QTech does, with executed audit reports to prove it.
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Technology-Native Auditing
QTech understands regulated systems from the inside — validated system lifecycles, audit trail architecture, SEND data pipelines, and IT security controls. We assess technology the way FDA does: by looking at what the data actually shows, not just what the SOP says.
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Risk-Based, Implementable Guidance
Compliance recommendations calibrated to your risk profile, program stage, and operational reality — built to be actionable, not theoretical documents filed and forgotten.
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SoCal-Based, Globally Capable
Headquartered in Southern California — the heart of US biotech. On-site globally, with full remote audit capability for international engagements and ongoing sponsor programs.
Zenith Khan
President & Principal Auditor
Zenith Khan is a senior GxP quality and compliance professional with more than 20 years of experience across the pharmaceutical, biotechnology, and medical device industries. Her career spans the full drug development lifecycle — from early-stage nonclinical research through clinical development and commercial manufacturing — giving her a rare, cross-functional perspective that few independent consultants can offer.
Having worked across every corner of the regulated industry — as a sponsor-side quality leader, at contract research and manufacturing organizations, and as an independent consultant — Zenith brings an unusually broad and operationally grounded expertise to every engagement. Her auditing experience covers the full GxP spectrum: GMP manufacturing and CDMO qualification, GLP and GCLP laboratory operations, GCP clinical programs, GDP distribution, pharmacovigilance, and advanced technology systems including computer system validation, SaMD, AI/ML platforms, and eClinical systems.
Zenith has served as Lead Auditor for major pharmaceutical and biotechnology sponsors, executing qualification, routine, and for-cause audits of CDMOs, CROs, clinical investigator sites, central laboratories, specialty pharmacies, and GxP technology vendors across the US, EU, and international markets. She has led global clinical development quality programs, managed regulatory inspection readiness, and built quality management systems from the ground up for emerging biotech organizations.
Holding a Bachelor of Science in Chemical Engineering from Malmö University in Sweden, Zenith combines a rigorous scientific foundation with multilingual capabilities and a record of operating across global regulatory environments — including US FDA, EMA, MHRA, and international ICH frameworks — positioning QTech Solutions as a consultancy that brings genuine scientific and regulatory depth to every program it supports.
Let's discuss your compliance challenges
Whether you're preparing for a regulatory inspection, building a quality system, need internal process audits, or require an independent expert evaluation of your critical systems — QTech Solutions is ready to help.
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