Analytical methods should be developed quickly but with sufficient sensitivity to control impurity profiles in drug substance or degradants in drug product. We have extensive experience in efficiently developing and validating quality methods, as well as release of clinical materials, stability studies and analytical investigation on key issues during drug product development. |
Drug Product Development
We provide a wide variety of analytical services to support every stage of drug product development. We will work with you to support all >>
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Stability Studies
We have all relevant stability chambers for API and formulated product, monitoring both chemical and physical stability. >>
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Method Development
Our method development plan is specific to each technique and product. All methods are documented in detail for straightforward inclusion into >>
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Release Testing
Our Regulated Analytical Lab follows strict cGMP criteria with state-of-the-art instrumentation combined with documented calibration and system suitability procedures >>
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Method Validation
Method validation must adhere to criteria outlined in regulatory documents such as ICH Q2. Our scientists have the expertise >>
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bio-equip.cn
Crystal Pharmatech is the first technology-driven, China based 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.
Founded in 2010, Crystal Pharmatech has business relationships with over 60 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.
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.