Our services prioritize

customer success

Implementation to Operations. We take on all lifecycle stages of compliance management so you can focus on your business.

  • After 400+ projects with 220+ customers; our services, software and methodology are informed by real customer success.

Quality Management Services

We combine insights gained from working with customers who have implemented the same systems, with transparent service delivery and management focused on measurable outcomes.

Strategic Advisory

  • SaaS Governance Model Strategic Implementation

  • Quality Management System Process Harmonization

Computer Systems Validation

  • Pre-Package Systems

  • Validation package

  • Customer-specific Implementation Validation

  • Software release and change management

SOP Accelerators

  • Pre-Packaged Quality SOPS

  • Pre-packaged System SOPs

Audit, Compliance and 

Remediation

  • Quality Management System Audit

  • CAPA / Consent Decree Remediation

  • Internal, External and Mock Auditing

Release and Change Management

Maintain compliance and facilitate innovation with a repeatable, reliable and resource-independent solution.

  • Realize the value of your SaaS investment and manage the performance gap.

  • Work with certified product experts focused on compliance.

  • Leverage benchmarks from our work across the industry and mature your processes.

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Our methodology brings our services and technology together to make things easier.

  • Transparent services delivery and management.

  • Pre-built validation packages, audit reports and supporting documents.

  • Software that automates customer CSV and Change Management SOPs.

Supported Solutions

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Staff Augmentation

We provide you with skilled people who adapt to your needs and follow your business processes.

  • Fully staff teams with precision and efficiency.

  • Individuals with specific skill sets are brought up to speed quickly and make immediate positive contributions to the project.

  • Adapt and increase agility with improved expense clarity.

We do the right thing

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We know how to focus on customer success

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We deeply understand GxP processes and associated technologies 

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We have worked in pharma, med-device, biotech, financial services, and tech

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We have worked in the US, EU, India, Japan

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We are diverse and inclusive