Driftpin's Services

Driftpin helps life sciences organizations and vendors align regulatory compliance, operational excellence, and technical execution.

Services: Assessment • Computer System Validation • AI Validation & Governance • Fractional Head of Quality • ISO Certification • GxP Compliance • System Implementation • M&A Due Diligence • Digital Strategy • Training & Competency • Change Management

Assessment: Discovery First, Always

Most quality and compliance problems get misdiagnosed. We assess what's actually blocking you before recommending solutions, ensuring you address root causes rather than symptoms.

What this prevents:
  • SOPs that don't match operational reality, creating audit risk
  • Training records scattered across systems, impossible to retrieve efficiently during audits
  • Validation strategies that predate AI and digital tools
  • Quality system integration failures post-M&A
  • Review and approval processes that create bottlenecks without improving quality
Client types: Pharmaceutical, Biotech, Medical Device, CROs, Technology Vendors Duration: 2-4 weeks for assessment

AI Validation & Governance for Regulated Environments

AI implementations shouldn't fail validation after deployment. We build governance and validation frameworks into AI systems from design, ensuring regulatory readiness without blocking innovation.

What this prevents:
  • AI models deployed without validation frameworks that can demonstrate reliability over time
  • Bias in training data that goes undetected until post-market surveillance
  • Model drift that invalidates original validation without triggering change control
  • Demographic stratification gaps that expose disparate performance across populations
Client types: Biotech, Pharma, Medical Device, Digital Health, AI Developers Duration: 2-6 months depending on system complexity

Computer System Validation (CSV)

Your audit prep shouldn't pull three people off revenue work for six weeks. We prevent validation rework through systematic workflow documentation that focuses testing on actual operational risks.

What this prevents:
  • Validation rework that doubles project timelines
  • Audit findings from undocumented system integrations
  • Testing protocols that miss critical data vulnerabilities
Client types: Biotech, Pharma, CROs, Medical Device Duration: 3-6 months typical

Fractional Head of Quality Services

Building quality infrastructure shouldn't require full-time executive hire before you have revenue. We provide strategic quality oversight that scales with your organizational needs and regulatory milestones.

What this prevents:
  • Investor diligence uncovering quality system gaps that threaten funding rounds
  • Regulatory submissions delayed by inadequate quality documentation
  • Inspection findings requiring systematic remediation without existing quality leadership
  • Board and executive team lacking quality/regulatory expertise for strategic decisions
Client types: Early-stage Biotech, Medical Device Startups, Digital Health, GxP Software Vendors Duration: 3-12 months typical, can transition to permanent hire

ISO Certification

ISO programs shouldn't create administrative overhead without improving performance. We design certification that builds genuine operational capability while satisfying audit requirements.

What this prevents:
  • ISO frameworks that become compliance theater instead of operational improvement
  • Supplier risk management that overwhelms teams while missing real vulnerabilities
  • Certification audits that expose gaps between documentation and actual operations
Client types: Biotech, Pharma, Medical Device, CROs Duration: 6-12 months for initial certification

GxP Compliance

Compliance gaps shouldn't be discovered during FDA inspections. We build GxP readiness into normal operations so audits become routine demonstrations of competence, not organizational fire drills.

What this prevents:
  • Audit preparation that pulls teams away from revenue work for weeks
  • Compliance findings that damage client relationships and market credibility
  • Manual data compilation during regulatory inspections
Client types: Pharmaceutical, Biotech, CROs, Medical Device Duration: 3-6 months for operational alignment

System Implementation

Your next system implementation shouldn't go 6 months over budget because nobody understood the data requirements. We prevent expensive surprises by documenting actual workflows and data dependencies before vendors start building solutions.

What this prevents:
  • Integration projects that discover scope gaps mid-implementation
  • Systems that work individually but can't support enterprise operations
  • Manual workarounds that create compliance vulnerabilities
Client types: Pharmaceutical, Biotech, CROs, Medical Device Duration: 4-8 months for major implementations

M&A Technology Due Diligence

Technology assessments shouldn't focus on feature inventories while missing operational integration complexity. We provide systematic evaluation of system architectures and post-merger harmonization requirements that inform transaction decisions.

What this prevents:
  • Integration cost estimates that miss critical workflow dependencies
  • Post-merger discoveries of undocumented system interdependencies
  • Technology assessments that ignore regulatory compliance transfer requirements
Client types: Private Equity, Strategic Acquirers, Investment Banks, Life Sciences Companies Duration: 4-8 weeks for comprehensive assessment

Digital Transformation Strategy

Digital initiatives shouldn't create technology overhead without improving operational outcomes. We help organizations approach technology modernization systematically while maintaining regulatory compliance throughout transformation.

What this prevents:
  • Technology portfolio rationalization where multiple systems lack integration planning
  • Cloud migration strategies that must maintain GxP compliance and operational performance
  • Legacy system modernization without disrupting mission-critical operations
Client types: Biotech, Pharma, Medical Device, CROs, CDMOs Duration: 3-6 months for comprehensive strategy

Training & Competency Management

Managing GxP training across 30-40 control documents shouldn't overwhelm your compliance team. We design systematic training programs with automated tracking and audit-ready documentation.

What this prevents:
  • Training matrices that get out of sync with actual SOPs and qualification requirements
  • Onboarding processes that take months due to manual training record management
  • Audit failures caused by incomplete or undocumented training records
Client types: Pharmaceutical, Biotech, CROs, Medical Device Duration: 2-4 months for initial program setup

Change Management Services

Technology transformations shouldn't disrupt validated processes or compromise compliance status. We provide executive-level change leadership that integrates quality systems with organizational development.

What this prevents:
  • System implementations that require process changes across multiple departments
  • Regulatory changes demanding organization-wide security and process updates
  • M&A integrations where different quality systems must be harmonized
Client types: Pharmaceutical, Biotech, CROs Duration: 3-6 months for major transformations