Novel Raw Materials Program Solves Regulatory Compliance Challenges in Small Molecule Drug Manufacturing

Merck have introduced a novel program to help process development scientists solve raw material quality, regulatory and procurement challenges that have plagued small molecule manufacturers. Merck launched the program at CPhI Worldwide, 9 - 11 October 2018, in Madrid, Spain.

The Chemiflex™ Critical Raw Materials program includes materials, documentation and contract manufacturing services that save time and prevent certain setbacks by ensuring that critical raw materials chosen for active pharmaceutical ingredient synthesis will be available in quantities and qualities suitable for cGMP manufacturing.

In the past, developers often encountered quality and supporting documentation challenges when sourcing critical materials for late stage development and commercial manufacturing. Merck’s new offering is intended to give customers increased confidence in their supply chain of critical raw material choices for small molecule drug synthesis.

Raw materials are the subject of increasing regulatory scrutiny. Merck’s Chemiflex™ program is a solution for the sourcing of high-quality, critical raw materials that meet increasing regulatory documentation and supply chain requirements for small molecule drug development and manufacturing.