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What We Do Differently

Inspection Readiness & Compliance AssuranceWe help organizations achieve inspection readiness by design rather than by crisis.Through mock inspections, gap assessments, remediation planning, CAPA effectiveness reviews, and leadership coaching, we enable sustained compliance and inspection confidence.

What We Deliver

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   Quality Management Systems (QMS) built for Usability and Execution

  • Fit-for-purpose QMS design and implementation

  • Documentation, training, supplier quality, validation, deviations, change management and data integrity

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   Operational foundations & Governance​

  • Scalable governance, processes, roles and responsibilities

  • Aligned to company size, development stage, and pipeline maturity

 

   Regulatory Compliance Readiness & Execution​

  • Inspection readiness and regulatory inspection support

  • Health authority interactions and communications

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   Operationalizing Quality

  • Quality integrated across internal manufacturing and CDMO/supply partners

  • Compliance built into day-to-day operations without slowing execution

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   Regulatory Filing, Approval & Launch Support

  • Hands-on partnership with regulatory teams throughout product approval and launch

  • Support for systems, processes, documentation, and facility readiness 

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   Post-Approval & Commercial Readiness

  • Operational support during scale-up and organizational build-out

  • Capability building for quality and compliance, including support for hiring and onboarding FTEs 

 

   Leadership Coaching & Capability Building

  • Coaching and development of future Quality leaders

  • Practical, confident decision-makers aligned with business objectives

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Scope of Support

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    For startups and emerging companies:

 

   We partner and act as an extension of the quality organization, supporting:

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  • Process development and operational readiness

  • QMS design and implementation (GMP, GDP, GLP, GCP)

  • Inspection readiness and regulatory inspections

  • Regulatory submissions and approvals support

  • CDMO selection, qualification, and oversight

  • Regulatory risk management and strategy

  • Health authority engagement and communications

  • Change management, deviation management, CAPA development and implementation

  • Packaging, artwork, and labeling compliance

  • Pharmacovigilance, complaints and adverse event reporting procedures, system set-ups and training​

   

    For Mid-Size and Scaling companies:

 

  • Assessment and rationalization of existing quality and regulatory foundations

  • Simplification of over-engineered documentation and the streamlining of procedures

  • Modernization of quality systems to align with current business needs and growth plans

  • Transformation of quality operations to support integration, merger or IPO readiness

  • Strategic use of AI across quality and operations to improve insight, efficiency, and execution

  • Cost reduction and productivity improvement through elimination of non value adding complexity

Our Clients 

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​We support pharma and biotech organizations, both in Human & Animal Health firms across North America, Europe, Latin America, and Asia Pacific, as they navigate increasing regulatory, quality and manufacturing complexities. â€‹

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Product & Technology Experience

 

  • Large Molecules - biological (vaccines, diagnostics), monoclonal antibodies (mAbs), and advanced biologic therapies

  • Small Molecules - sterile and non-sterile drug products 

  • Medical devices - across risk classes and regulatory pathways

  • Combination products

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The Challenge We Address

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1) Emerging Pharma & Biotech Organizations

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Innovative companies are advancing novel therapies with the potential to significantly improve patient outcomes. As these organizations transition from development to regulatory approval, manufacturing and commercialization, execution often becomes the limiting factor. The challenge often lies in operationalizing quality, regulatory and manufacturing strategies at the speed and scale growth demands. 

 

 

2) Mid-Size & Scaling Organizations

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As organizations grow, organically or through acquisitions, quality frameworks frequently become overly complex, fragmented, and misaligned with business objectives. This leads to inefficiency, frustrated teams, increased operational risk, and rising costs.

 

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