Precision. Integrity. Excellence.

OUR SERVICES

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.

our services SPC

Third-Party Audit Services

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

 

Quality Management System (QMS) Support

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

 

Batch Record Review

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

Training & Capability Building

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

Regulatory Licensing Services

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

Analytical Testing Support

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

Consulting & Strategic Advisory

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

Calibration Services

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