Hale CMC Solutions

Hale CMC Solutions is a consulting firm supporting the biotech industry for small molecule chemistry, manufacturing, & controls (CMC) needs. We have over 10 years of experience at small biotechs and large pharmaceutical organizations supporting all aspects of pre-clinical to Phase 3 cGMP and non-GMP manufacturing of custom APIs, intermediates, and regulatory starting materials using an outsourced model. We work with an extensive network of 3rd party PR&D and manufacturing sites in North America, Europe, India, and Asia to support deliveries ranging from 100+ grams to 100+ kilograms. In particular, we have extensive experience in pre-clinical through Phase 2 clinical deliveries, including IND tox batch strategy & manufacturing, initial FIH IND/IMPD data packages & CTD Module 3 authoring, and early-stage first cGMP batch manufacturing. We are able to support you in many areas of small molecule drug substance activities, including: -route scouting and route selection -process optimization -manufacturing under GMP or non-GMP -outsourced manufacturing support -solid form screening (polymorph and salt screen) -form characterization and selection -API and intermediate crystallization development -particle size control -Phase-appropriate impurity control strategies (ICH Q3A, Q3C, M7, nitrosamine) -stability studies and strategy -stable-isotopic label (SIL) synthesis -regulatory starting material (RSM) justification -CTD Module 3 authoring for IND/IMPD submission -impurity fate/spike/purge -preformulation studies and enabling formulation development Contact us at hale.cmc.solutions@gmail.com