Services
Quality services across the product lifecycle
Quality Assurance (QA)
Ongoing QA and regulatory support across preclinical, clinical, and commercial stages: quality systems (QMS), SOP development and review, batch record review, quality investigations, deviation and CAPA management, change control, risk assessments, document control, data integrity and good documentation practices (GDP), supplier quality management, manufacturing and QC support, training program support, and continuous improvement.
Audits & Regulatory Compliance
Internal, supplier, and quality-system audits that identify compliance gaps, recommend corrective actions, and support audit and inspection readiness. Experience includes U.S. FDA regulations, ISO quality standards, Health Canada (HC), the European Medicines Agency (EMA) and applicable EU regulations, Japan's PMDA, and Brazil's ANVISA.
Commissioning, Qualification & Validation (CQV)
Commissioning, qualification, and validation support for facilities, utilities, systems, and equipment to demonstrate fitness for intended use and alignment with industry expectations.
Project Management
End-to-end coordination of compliance, facility qualification, remediation, and product life-cycle initiatives — aligning stakeholders, schedules, risks, documentation, and deliverables.
AI-Enabled Quality, QMS & Compliance
AI-supported approaches incorporated across QA, QMS systems, audits, CQV, and project management to assist with document review, gap identification, trend visibility, workflow organization, and decision support — while maintaining appropriate human quality oversight.
Quality Assurance
Flexible engagement options
Choose the level of QA support that fits your program — from a fully embedded quality partner to targeted, task-based deliverables.
Dedicated Partner
Long-term · Full-time
6+ months · 40 hrs / week
- Embedded QA Support Acting as an Extension of Your Quality Unit
- Full Ownership Of Ongoing QMS Activities and Quality Oversight
- Supplier Quality: Support Supplier Qualification, Onboarding Audits, Material Onboarding, and Supplier Risk Assessments
- Client Quality Leadership: Serve As the Quality Point Of Contact For CDMO Clients From Engineering Support, Tech Transfers Through GMP Manufacturing Support
- Priority Response and Dedicated Point Of Contact
Flexible Support
Long-term · Part-time
Ongoing · up to 20 hrs / week
- Steady QA Coverage Without A Full-Time Headcount
- Quality Documentation / Disposition: Document and Batch Record Review On A Recurring Cadence
- Deviation, CAPA, and Change Control QA Support Or Ownership As Needs Arise
- SOP Maintenance and Continuous Improvement
- Scale Hours Up Or Down As Your Workload Changes
- All Tasks and More From Dedicated Partner
Task-Based
Short-term · Project scope
Defined scope · per deliverable
- Backtrack and Retrospective Record Review
- SOP Build-Outs and Controlled-Document Development
- Specific Protocol Writing (Validation, Qualification, Etc.)
- Remediation Support and Gap Closure
- Clear Deliverables, Timelines, and Fixed Scope
- All Tasks From Dedicated Partner and Flexible Support
Audits & Regulatory Compliance
Flexible engagement options
Engagement options for audit programs, retained compliance support, and one-time assessments across FDA, ISO, EMA, Health Canada, PMDA, and ANVISA frameworks.
Embedded Audit Partner
Long-term · Program-led
6+ months · full or part-time
- Act As Your Audit Program Lead and Compliance Liaison
- Plan and Manage Internal, Supplier, and Quality-System Audit Schedules
- Track Findings, CAPA, and Inspection-Readiness Metrics
- Support Continuous Audit and Inspection Preparation
- Priority Access For Urgent Regulatory Questions
- Internal Audit Support, and Supplier and Client Audits
Retained Audit Support
Ongoing · As-needed
Recurring · scheduled audits or review cycles
- Conduct Periodic Internal Or Supplier Audits On A Retainer Basis
- Review and Update Audit Procedures and Checklists
- Support Inspection Readiness Between Audits
- Gap Assessments Against FDA, ISO, EMA, HC, PMDA, Or ANVISA Expectations
- Flexible Scheduling Around Your Program Needs
- Internal Audit Support, and Supplier and Client Audits
Standalone Audit & Gap Assessment
Short-term · Defined scope
Single audit or assessment · per deliverable
- One-Time Internal, Supplier, Or Mock Regulatory Inspection
- Focused Gap Assessment Against A Specific Regulation Or Standard
- Written Findings Report With Corrective-Action Recommendations
- Support For Regulatory Response Or Remediation Planning
- Clear Scope, Timeline, and Final Report
- Internal Audit Support, and Supplier and Client Audits
Commissioning, Qualification & Validation
Flexible engagement options
Flexible CQV support from program leadership to discrete validation deliverables for facilities, utilities, systems, and equipment.
CQV Program Lead
Long-term · Embedded
6+ months · full or part-time
- Lead Commissioning, Qualification, and Validation Strategy
- Own CQV Documentation, Schedules, and Stakeholder Coordination
- Support Facility, Utility, Equipment, and System Qualification
- Align CQV Activities With Regulatory and Quality Expectations
- Dedicated Point Of Contact For the Validation Lifecycle
Targeted CQV Support
Mid-term · Phase-specific
Project phase · flexible hours
- Support Specific Qualification Or Validation Phases As Needed
- Draft Or Review IQ/OQ/PQ Protocols and Summary Reports
- Assist With Commissioning Handoffs and Acceptance Testing
- Track Deviations, Change Control, and Closure Activities
- Scale Support Up During Peak Validation Activity
Specific Validation Deliverable
Short-term · Task scope
Defined deliverable · per protocol or report
- Single Protocol Or Report Writing (IQ, OQ, PQ, PV, IOQs, Etc.)
- Gap Review Of Existing CQV Documentation
- Risk Assessment and Impact Analysis Support
- Commissioning Or Qualification Execution Support
- Clear Acceptance Criteria and Final Documentation
Project Management
Flexible engagement options
Project management options for long-term program leadership, initiative oversight, or focused remediation and rollout support.
Program / PMO Lead
Long-term · Strategic oversight
6+ months · full or part-time
- Act As Program Manager Or PMO Lead For Compliance Initiatives
- Own Schedules, Risk Registers, Stakeholder Communication, and Reporting
- Coordinate Cross-Functional Teams and External Partners
- Drive Remediation, Qualification, Or Product-Lifecycle Programs
- Executive-Level Status Updates and Escalation Support
Ongoing Project Oversight
Mid-term · Initiative-specific
Project duration · flexible hours
- Manage A Specific Compliance, CQV, Or Remediation Initiative
- Track Milestones, Risks, Issues, and Budget Against Plan
- Facilitate Working Sessions and Maintain the Project Schedule
- Ensure Documentation and Deliverables Align With Quality Requirements
- Adjust Resourcing As the Project Evolves
Discrete Project or Remediation
Short-term · Scoped effort
Defined scope · per project
- Jump Into A Specific Remediation, Gap Closure, Or Rollout Effort
- Define Scope, Timeline, and Deliverables At Kickoff
- Coordinate Tasks and Communications Until Completion
- Hand Off Clean Documentation and Closeout Summaries
- Clear Exit Criteria and Final Report
Speaking Engagements
Talks, lectures, and events
RossPharma Solutions speaks at industry conferences, universities, and company events on quality, compliance, and audit readiness — sharing practical perspective from work across pharmaceuticals, biotechnology, medical device, and defense.
Industry Conferences & Panels
Presentations and panel discussions on quality systems, audit and inspection readiness, CQV, and emerging compliance expectations — tailored to audiences across pharmaceuticals, biotechnology, medical device, and defense.
University Lectures & Guest Sessions
Guest lectures and seminar sessions that connect classroom theory with real GMP and quality practice: regulatory frameworks, documentation, investigations, and career paths in quality and compliance.
College & Career Fairs
Presence at college career events — talking with students about entering the life-sciences quality field, what employers look for, and how to build relevant experience.
Job Fairs & Recruiting Events
Representation at job fairs and hiring events: describing open roles and consulting engagements, and answering candidate questions about QA, audits, CQV, and project management work.
Company-Building Events
On-site and virtual company events — lunch-and-learn sessions, quality awareness talks, and team workshops that reinforce a strong quality culture across your organization.
Selected capabilities
- FDA / ISO / International Audit and Inspection Readiness
- Internal, Supplier, and Quality-System Audits
- QMS Support
- SOP and Controlled-Document Review
- Batch-Record Review
- Quality Investigations
- Deviation / CAPA / Change Control
- Risk Assessment and Data Integrity
- Manufacturing and QC Support
- Clinical-to-Commercial Quality Transition
- Facility, Utility, and Equipment Qualification
- Compliance Remediation and Project Execution