BIOPHARMACEUTICAL COLD CHAIN ENGINEERING

“Modality Solutions developed the distribution validation strategy for our antibody-drug conjugate. They drafted all required protocols, supported the validations execution and finalized all reports. Modality Solutions hard work resulted in the regulatory authority approval and acceptance of the distribution validation. Team members Brian and Rachel were hard working, responsive, and dedicated to the success of this effort.”

“Success! ANVISA accepted our proposal for concurrent PQ shipments! What a huge win! Again, thank you for helping us have such a robust plan and data.”

“Their integrated team approach brought immediate benefits to my team by augmenting our skills on several project teams simultaneously. They were valued members of the team the first day on the job!”

“Modality Solutions offers deep expertise in the area of logistics validation. They were instrumental in delivering our cold chain validation during launch and went above and beyond to accommodate short timelines. The folks at Modality Solutions are collaborative, responsive, and it’s a pleasure to work with everyone on the team.”

“As a pure-play biosimilar, we needed guidance and execution assistance for one of the first ever FDA biosimilar filings. We engaged Modality Solutions to help us get our cold chain ready to file. We wanted to make sure we got it right, so we called the best. Their experience & expertise was invaluable.”