Quality, Regulatory & Compliance

For life sciences companies that can quickly address and mitigate regulatory & compliance issues, opportunities abound. With regulatory leadership experience, rapid response, and precisely matched talent, EG Life Sciences can help you surpass competitors mired in the complexity and rigor of challenges that you address with ease.

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Mitigating Roadblocks, Navigating Regulatory Minefields, All While Ensuring Compliance

EG Life Sciences can help you achieve success by linking in-demand and highly skilled experts to you and your projects.

Our consultants have thousands of hours of quality assurance and control expertise. We have helped clients respond to regulatory citations, remediate issues raised in 483 warning letters, and design and manage Corrective and Preventative Action (CAPA) workstreams. We have also helped clients harmonize quality management systems post-acquisition and bring newly acquired product lines into compliance. With a combination of experience, rapid response, and exactly matched talent, we help you fill the skill gaps in your teams with top tier experts to ensure momentum and success.

Across hundreds of engagements, EG Life Sciences has helped the largest and most sophisticated life sciences companies get their innovations to market and keep them there.

Our Core Competencies

Our Core Competencies within Quality, Regulatory & Compliance include the following areas:
  • Audits and Audit Preparedness
  • Cellular and Gene Therapies
  • Clinical Evaluation Reports (CER)
  • Clinical Compliance
  • Clinical Trial Management
  • Chemical, Manufacturing, and Controls (CMC)
  • Commissioning, Qualification & Validation
  • Computer System Validation (CSV)
  • Design Quality Engineering
  • Engineering
  • Facilities/Utilities/Equipment/Process Val
  • Medical Affairs
  • Medical Writing
  • Pre-Post Market Surveillance
  • Product Advertising and Promotion
  • Quality Management Systems (QMS) Harmonization
  • Quality Management Systems (QMS) Management
  • Quality Assurance and Control
  • Regulatory Affairs Program and Project Leadership and Management
  • Regulatory Affairs Submission Support (Strategy, Execution, and Submission Support)
  • Resource & Demand Management
  • Risk Management
  • Software as a Medical Device (SaMD)
  • Statistical Analysis Software (SAS) / Statistical Programming
  • SKU, Labeling
  • Standard Operating Procedures
  • Supplier Quality
  • Tech Transfer
  • Total Product Life Cycle
  • EU MDR and IVDR Risk Management and Compliance

Remediation Plan to Address FDA Consent Decree

A remediation project saves a global device firm $200 million in recalls and penalties.

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How do we deliver scalable and flexible solutions?

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