SPC specializes in practical, audit-ready support across the full spectrum of pharmaceutical, biologics, and medical device quality functions.
We strengthen systems, empower teams, and ensure your organization is fully inspection-ready.
At Streamlined Pharma Compliance (SPC), we provide a comprehensive suite of quality, regulatory, and compliance services designed to support pharmaceuticals, biologics, and medical device organizations at every stage of their operational lifecycle. With a strong foundation built on more than 25 years of industry experience, our services are crafted to be practical, audit-ready, and aligned with international regulatory expectations including FDA, EMA, Health Canada, ICH, and ISO standards. We help companies strengthen their Quality Management Systems, streamline documentation, enhance lab operations, improve inspection readiness, and maintain continuous compliance across GMP, GDP, GVP, and regulatory frameworks. From independent third-party audits and real-time batch record reviews to strategic consulting, risk management, licensing support, training programs, and laboratory oversight, SPC delivers solutions that are tailored, actionable, and grounded in real-world operations. Our goal is to empower teams, minimize compliance risk, fortify processes, and ensure that your organization is consistently prepared for regulatory inspections, product releases, and global market approvals. Whether you require operational support, system optimization, regulatory strategy, or specialized compliance oversight, SPC serves as your trusted partner for achieving excellence in quality and regulatory performance.
Independent audits tailored to GMP, GDP, GVP, and ISO standards.
Our audits help organizations evaluate compliance, qualify suppliers, and prepare confidently for regulatory inspections.
What we offer
Supplier qualification and vendor audits
Mock inspections and gap assessments
Comprehensive audit reports with prioritized CAPAs
Confidential, respectful, and solutions-focused audit approach
Design, implementation, and optimization of compliant, practical QMS frameworks.
We build quality systems that integrate seamlessly into operations — improving efficiency, consistency, and regulatory alignment.
Our QMS Expertise
SOP development, review, and harmonization
eQMS configuration, workflow design, and validation
Deviation, CAPA, and change-control system support
Risk-based planning and data-integrity implementation
Thorough documentation review to support compliant product release.
We provide real-time and retrospective batch record audits aligned with global standards (FDA, EMA, Health Canada).
Our Review Services
Detection of documentation gaps and recurring errors
Review aligned with FDA, EMA, EU-GMP, and Health Canada expectations
Support for hybrid and electronic batch records
Clear, actionable comments to improve documentation culture
Customized training programs to build regulatory awareness and operational excellence.
We deliver engaging, role-based sessions to enhance compliance confidence across QA, QC, production, and leadership.
Training Programs Offered
GMP, GDP, GVP, and data-integrity fundamentals
Audit preparedness & inspection behavior workshops
Technical training tailored to QA, QC & manufacturing roles
Comprehensive onboarding programs & assessments
End-to-end support for Canadian and international licensing requirements.
We help clients navigate complex regulatory frameworks with precision and clarity.
Our Licensing Expertise
Site licensing (DEL, MDEL), product registration & renewals
Regulatory strategy development
Dossier preparation (CTD/eCTD)
Communication with Health Canada & global regulatory authorities
Support for post-approval changes, commitments & compliance updates
Strategic oversight for in-house and outsourced laboratory operations.
SPC ensures your lab meets regulatory expectations while delivering reliable, consistent, and defensible results.
Our Lab Support Includes
Method validation & method transfer coordination
OOS/OOT investigations and root-cause analysis
Laboratory audits & data-integrity reviews
Protocol preparation and trending report support
Third-Party Testing Coordination
SPC coordinates testing through Health Canada–approved laboratories.
You simply ship the sample — we manage everything else, including:
Documentation review
Certificate of Analysis (CoA) review
Regulatory alignment and reporting
Expert guidance for regulatory strategy, system improvement, and inspection readiness.
We provide confidential, collaborative consulting based on decades of real industry experience.
Our Advisory Services
Audit-readiness (mock audits, document room setup, facility walkthroughs)
Inspection behavior coaching & team preparedness
Compliance remediation & inspection response
Facility qualification support (IQ/OQ/PQ)
Tech transfer planning & process validation support
Gap analysis, risk assessments & quality roadmaps
Full calibration coordination through qualified third-party vendors.
We ensure your equipment calibration meets GMP/ISO expectations with complete documentation and traceability.
Calibration Support Includes
Scheduling & vendor management
Calibration certificate review and verification
SOP development & integration into the QMS
Preventive maintenance planning
Audit-ready calibration records & traceability audits
248 Brisdale Dr.Brampton. L7A 2T3, ON, Canada
+1 647 493 8684