Strategic focus that drives your success to the finish line.

ValCom Consulting brings trusted leadership and deep expertise to support organizations across the biotechnology industry.

From emerging clinical-stage cell and gene therapy firms to leading pharmaceutical manufacturers, our founding members bring over 50 years combined experience to the biotechnology industry.

• Quality Engineering /
  Quality Assurance Validation

• Quality Systems Support
  (CAPA, Change Control, Deviations)

• Supplier Quality Management

• Batch Record Review

• Audit Readiness – Audit Support

• Risk Evaluations and Gap Assessment

Get your project done fast.

Find out how ValCom Consulting can support your success.

• Air Flow Visualization /
  Environmental Monitoring Performance Qualification (EMPQ) Facilitation and Support

• FUE Design and Management

• Annex 1 Readiness

• Commissioning, Qualification, and
  Validation Support

• Validation Maintenance

• Analytical Instrumentation Qualification

• Computer System Validation Support

• Facility and Utilities Verification

• FAT / SAT Support

• Enterprise System Planning and Implementation

• SOP and Document Writing for CGMP

• Building Automation System Commissioning and Qualification

Our Services

QUALITY

CQV

MANAGEMENT

• Overall Project Management to Support the Engineering Lifecycle
  (Design to Facility Fit and Finish)

• Facility / Suite / Laboratory Expansion

• Tech Transfer

• Consent Decree Remediation

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