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
Company Details
- Founded
- -
- Industry
- Pharmaceutical Manufacturing
- NAICS
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Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
Hale Cmc Solutions Questions
Hale Cmc Solutions's LinkedIn profile is https://www.linkedin.com/company/halecmcsolutions
Hale Cmc Solutions's industry is
Pharmaceutical Manufacturing
Hale Cmc Solutions's top competitors are
Lunali Cmc Solutions,
Elfgren Consulting,
Sailam Llc,
Coverant,
Amgen,
Hande Sciences,
Astellar Labs,
Tenvie Therapeutics,
Denali Therapeutics,
Precise Peg Llc.
Hale Cmc Solutions's categories are Pharmaceutical Manufacturing
Hale Cmc Solutions's founding year is 2024
