• Quality Assurance & Control

    Quality Assurance & Control

    1. Specification Development and Review
    2. Process Establishment, Implementation, and Improvement initiatives
    3. Inspection, Test and Operating Methods
    4. Management of Nonconforming Materials, Parts or Components
    5. QA/QC Records
    6. Control of Special Processes
    7. Control of Manufacturing, Inspection and Test Equipment
  • Validation

    Validation

    1. Master Validation Plan (MVP) Development
    2. Process Validation (IQ, OQ, PQ)
    3. Equipment Qualification
    4. Cleaning and Sterilization Validation (ex. – SIP, Autoclave, ETO, Gamma, etc.)
    5. Systems and Software (i.e. - 21 CFR part 11, electronic records, etc.)
    6. Packaging/Storage Stability and Labeling
    7. Test Method and Assay Validation
  • Quality Management Systems

    Quality Management Systems

    1. Assessments, GAP Analyses, and Optimization
    2. Implementation and Turn-key Project Management
    3. ISO Certification & Product CE Marking
    4. Management Responsibility Training and Coaching
    5. Deviation and CAPA Management
    6. Mock Regulatory Agency (FDA, Notified Body, etc.) Audits and Inspections
  • Compliance

    Compliance

    1. Third-party GMP & GLP Compliance Auditing
    2. GAP Assessments
    3. Mock FDA/Notified Body Audits
    4. Due Diligence Compliance Inspections, Audits & Assistance
    5. FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation
  • Regulatory Affairs

    Regulatory

    1. Regulatory Submissions (ex.- Premarket Approval PMA, 510(k), CE Mark, INDs, ANDAs, etc.) and Compliance
    2. Labeling, Advertising, and Promotional Materials Review
    3. EU Medical Device Expertise
    4. Technical File and Design Dossier Preparation
    5. Management of Notified Body Audits
    6. Remediation of FDA 483 Observations/Warning Letter/Consent Decree
  • Project Management

    Project Management

    1. Project Planning
    2. Budget Establishment, Analysis, and Tracking
    3. Resource Allocation and Management
    4. Project Scope Definition
    5. Coach, Mentor, and Train other PMs, Functional Leaders, and Team Members
    6. Success Measures and Metrics

EG Life Sciences is a professional consulting services firm that delivers flexible, scalable solutions for Pharmaceutical, Biotechnology, and Medical Device companies, including the resources they need to meet the unique challenges of FDA regulations.

Our internal staff is comprised of a team of leaders who are FDA regulated healthcare industry veterans with significant technical knowledge and expertise. In addition, the practice is also supported by a seasoned technical recruiting and project delivery/support team. This combination allows us to quickly deliver value-driven consulting, interim leadership, technical project management, and project based staffing solutions.

When partnering with EG Life Sciences, our clients receive highly skilled professionals who are rapidly deployable on a national scale.  These experts hit the ground running – working to produce high-level results – that are strategically delivered on time and within budget.

Services

EG Life Sciences Consulting provides clients with the ability to increase workload while ensuring compliance & quality within a regulated environment.

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Consultant

EG Life Sciences Consulting is growing fast and we have the connections you need to get the Life Sciences jobs you want.

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  Core Values

At EG Life Sciences, we are strong as individuals but even stronger when we combine resources and work together as a group. Collaboration results in innovation. We believe diversity in backgrounds, thoughts, and ideas foster innovation.  EG Life Sciences encourages a work environment where creativity, debate and continuous improvement are valued.

We strongly believe it's imperative to support the communities that the Life Sciences group serves. Our Community program is designed to provide both company and individual volunteer time, donations and fundraisers to help organizations in need throughout the US.