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BACKGROUND

EHL Pharma, LLC was founded in 2003 to provide start-up services and pharmaceutical consulting services to generic pharmaceutical companies worldwide. With our expertise in Manufacturing, Analytical Services, Product Development, Quality Assurance and Regulatory Affairs, we assist in starting up generic pharmaceutical companies or separate departments of generic pharmaceutical companies such as: Analytical Laboratories and Product Development Laboratories, Manufacturing, Regulatory Affairs and Quality Assurance. We provide hands-on assistance in building up your companies and departments.

AREAS OF EXPERTISE

Analytical Laboratory Start-Up

  • Quality Control Laboratories

  • Analytical Research and Development Laboratories

  • Instrumentation

    • Selection

    • Validation

    • Implementation

  • SOP Development

  • Method Development and Validation

  • Selection and Training of Personnel

Product Development Laboratory Start-up

  • Product Development Laboratories

  • Scale-Up Laboratories

  • Equipment

    • Selection

    • Validation

    • Implementation

  • SOP Development

  • Product Development

  • Selection and Training of Personnel

Regulatory Affairs Start-Up

  • Master Validation Plan Development

  • Document Control System Development and Implementation

  • ANDA Submission System Implementation

  • Selection and Training of Personnel

Manufacturing Start-Up

  • Equipment

    • Selection

    • Validation

    • Implementation

  • SOP Development

  • HVIC validation

  • Selection and Training of Personnel

Quality Assurance Start-Up

  • ​​​​Cleaning Validation Program Development and Implementation

  • Selection and Training of Personnel

EHL Pharma LLC

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