Pharmaceutical Consulting

Smart Consulting Group provides expert technical and regulatory support for biotechnology, medical devices, pharmaceuticals, vaccines, and specialty products, solving complex challenges for both the industry and governments.

How Smart Consulting Can Help

Data Integrity Audits

Scientific and Regulatory Due Diligence

Technology Transfer Strategy and Oversight

Technology Readiness Assessments (TRAs)

Quality Management System Strategy and Implementation

FDA GMP Compliance Assessments

Audits: GMP, GLP, GCP and ISO

Training: Including GxP, Data Integrity, FDA Inspections

Market Research and Analysis

Subject Matter Expert Staffing

Data Integrity Audits

Conduct complex data analysis of FDA regulatory submissions and manufacturing and testing data to confirm data integrity, quality, process integrity.

Our services

  • Training

  • Quality System Design and Implementation

  • Data Integrity Audits

  • Technology Readiness

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“I commend you for the great job you did. You showed a high level of professionalism. This type of outcome proves we chose the right company to work with.”

— C. R., Government Client