Integrated Services

  • WMA
  • IND/IMPD
Dossier
  • Stress polymorph and salt screens to protect IP
  • Obtain all relevent physical property data to support process
  • Complete full CMC section
  • Set all physical property specifications with validated methods
  • Amend patent application
Pre-Market Formulation
  • ldentify critical process parameters for API and drug product
  • Test physical stability
  • Develop and validate methods for critical quality attributes
  • Update IND
  • Amend patent application if needed
  • Lifecycle Management
First in Humans
  • Stress from screens
  • Screen solvents for crystallization yield, productivity and quality attribute control
  • Map out phase relations to understand API system, guarantee isolation and maintenance of desired phase in manufacturing
Preclinical
  • Stable from screening
  • Check propensity to stay as or from solvates/hydrates
  • Assess and screen for disproportion risk
  • pKa, log P
  • Submit polymorph patent application

ABOUT US

  • Introduction
2010

Founded in 2010, Crystal Pharmatech has business relationships with over 500 global pharmaceutical companies. High quality service, a culture of confidentiality, and fast turnaround with cost-effective pricing are our trademarks. As we continue to grow, Crystal Pharmatech will always keep customers our number one priority. We will also continue to be at the forefront of innovation in the field of solid-state chemistry so that our customers can reap the benefits of key discoveries in an ever changing field.

CRO

Crystal Pharmatech is a technology-driven contract research organization (CRO) that focuses on materials science and engineering for drug development. We partner with clients to ensure comprehensive solutions for their needs in solid-state research, crystallization process development, and preformulation studies. We guide clients in the discovery and selection of the optimal solid phase for drug development using all aspects of pre-formulation studies, including API process and formulation development, regulatory support and intellectual property protection.

External projects

Our Scientific Advisory Board includes global leaders in drug development covering amorphous dispersions, co-crystals, crystallization, solid forms, formulation and pre-formulation. The role of our board is all encompassing while we search for new scientific areas for internal and external projects.