Transactional Content Management

PRODUCTS

  • In today’s competitive and capital-constrained cell and gene therapy environment, early decisions around Chemistry, Manufacturing, and Controls (CMC) can make or break a therapy's timeline, cost-efficiency, and eventual approval. Yet many emerging cell therapy companies struggle with CMC strategy until it becomes a bottleneck.

  • Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.

  • PHCbi brand's 29.8 cu.ft (845L) large volume ultra-low temperature freezer delivers reliable temperatures as low as -86°C. This high capacity upright freezer is ideal for use in biorepositories, research freezer farms and facilities where bulk storage of sensitive biological material is managed. Its automatic vacuum relief port equalizes pressure and permits the outer door to be opened easily for quick re-entry.

  • PHCbi brand's 17.8 cu.ft (504 L) biomedical ECO freezer utilizes environmentally friendly hydrocarbon refrigerants. This unit leverages innovative variable speed inverter compressors to deliver efficient cooling and responsive recovery time after door openings. It provides a stable and reliable environment for storage of enzymes, vaccines, pharmaceutical products, and other biomedical materials with uniform temperatures. 

  • Ensuring the integrity of results and maintaining regulatory compliance are paramount concerns for any lab today, especially with increasingly complex laboratory processes. Cloud-based device management offers several advantages for laboratory equipment monitoring.

WHITE PAPERS AND CASE STUDIES

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