Last month, the FDA approved tafasitamab-cxix (official name Monjuvi®) in combination with Lenalidomide as a...
Working with Modality Solutions gives clients the distinct advantage of having three firms integrated into one.
The company functions as a packaging design, testing services and validation engineering firm. With more than 100 combined years of experience, Modality Solutions is one of the top choices for cold-chain management support.
Modality Solutions provides insight into cold chain thermal packaging, transport validation and logistics solutions with biologics, pharmaceuticals and medical device combination products. Experienced guidance and subject-matter direction are necessary to design processes, qualify packaging systems and verify/monitor your controlled-environment logistics networks.
The company’s team safeguards the security of clients’ product supply chain by developing the standards, policies, procedures and processes.
Developers and scientists, consider these decisions as an important step in reducing regulatory risk, while reducing the product approval cycle time.
Modality Solutions can deliver:
- Expertise and techniques to assess, control and communicate risk under an ongoing management review process
- A lifecycle approach concerning process validation, including design, qualification, and verification
- Improved integration of product formulation, controlled environment logistics and packaging design
- Innovative quality controls, corrective and preventive actions (CAPA) strategies, as well as root cause analyses
- Technology to achieve improved benefits in compliance, quality and safety
- Medical and clinical monitoring, product safety, and project management for clinical trial operations worldwide
Immunomedics (www.immunomedics.com) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment...
Covid-19 and the Race to Get a Vaccine Through FDA’s Supercharged Fast Track Approval Named Coronavirus Treatment Acceleration Program (CTAP)
The Coronavirus Treatment Acceleration Program launched by the FDA in response to Covid-19 is a...
Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets - these are some of...