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Chemistry Manufacturing and Control

Chemistry Manufacturing and Control (CMC) encompasses the development, testing, documentation and registration of a new pharmaceutical product, the production process and associated analytical methods.

  • PPQ

    The pharmaceutical industry is one of the most intensely regulated industries. One regulatory requirement is to validate the process to ensure that...

  • Analytical development and Stability...

    Analytical developmentAnalytic method development is a key element of any pharmaceutical drug development program. Reliable and reproducible...

  • Process Development

    Process development comprises the early development at laboratory scale through late development at commercial manufacturing scale. This process...

  • Quality by Design (QbD)

    Quality by Design (QbD) is a systemic approach to pharmaceutical drug development that begins with predefined objectives and emphasizes product and...

  • Chemistry Manufacturing and Control

    Your partner in Chemistry Manufacturing and Control

    Chemistry Manufacturing and Control (CMC) encompasses the development, testing, documentation...

  • QbD and QRM Implementation

    Quality by Design (QbD) and Quality Risk Management (QRM)Quality by Design (QbD) is a relatively new approach to product and process development for...

  • Technology Transfer

    Projects relating to technology transfer, or TOT (Transfer of Technology), involve the transfer of knowledge and information. Examples are the...

  • Workshop QRM and QbD

    Progress-PME also offers the ‘Introduction to QbD and QRM’ workshop for managers in the (bio)pharmaceutical industry. Click here for more...

  • Continued Process Verification

    In the past, validation of commercial manufacturing processes comprised three validation batches and was then considered complete. Since 2011...

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