Alchem Drug Development

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Drug Development
	Alchem is registered with the Food and Drug Administration as a drug establishment and its operations are in compliance with Good Manufacturing Practice guidelines of the FDA.

Drug Discovery	Design of active analogs Synthetic method evaluation Synthesis of drug substances
Pre-clinical Phase IND	Scale-up Process and analytical method development Reference standard validation Stability studies
Clinical Phases	Process optimization and validation Analytical method validation cGMP production for clinical trials
New Drug Application	CMC support Drug master files