Newsletter | June 6, 2024

06.06.24 -- Staying Up-To-Date With The Regulatory Digital Transformation

Achieving Excellence In The Regulatory Digital Transformation

The COVID-19 pandemic demanded significant pivots, and technology became critical for continued regulatory operations, including carrying out virtual inspections to assess drug safety and adherence to GMP. Key decision-makers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

"Ultra High” Potency Development And Manufacture

A biotechnology company with limited experience in the development and manufacture of high potency compounds needed to develop a process for producing a highly potent API, a DNA alkylator, used to treat an unmet oncology need, and wanted a partner for pre-clinical development and clinical trial material manufacture.

Speed To Market – API Large-Scale Commercial Manufacturing

A top 20 US-based pharma company required more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection (PAI). Learn how their CMO partner completed the project for the creation of a new commercial manufacturing facility while achieving the increased volume demand.

Adapting To Change – API Custom Development And Manufacturing

A top 100 European-based pharmaceutical company sought a development and manufacturing partner to assist with development work and scale-up to commercial manufacturing for a molecule in clinical Phase II/III trials where the chemistry required was particularly challenging.