Forms Processing

PRODUCTS

  • Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.

  • inSeption’s Clinical Operations and Project Management subject matter experts are integrated into the client’s project team, thus ensuring a more streamlined approach to providing the required support and/or recommending ways to achieve new efficiencies.

  • When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.

    Does an isolator need to be ergonomically unfriendly to clean?

    Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).

    Does routine maintenance have to be time-consuming and laborious?

    Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?

  • Zelta’s EDC has been used in more than 4,000 studies from startup to submission, across all phases, including over 500 phase 3c trials and 23 therapeutic areas.

  • Managing documents, training, and business processes are nightmares shared by all pharmaceutical and biotech companies and MasterControl provides pharmaceutical quality management software systems to take them out from that nightmare. MasterControl's QMS software exchanges the nightmares for a dream of a solution that enables pharma companies get their products to market faster and improve compliance at the same time. MasterControl pharma QMS software has been specifically designed to help manage all documents and automate regulatory-related processes and training in a single platform.

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