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Method Development, Validation and Transfer Services |
Integrated Analytical Laboratories, LLC (IAL) routinely performs many different types of
Integrated Analytical Laboratories, LLC (IAL) offers comprehensive method development,
method validation and transfer services through a specialized staff of knowledgeable and
experienced pharmaceutical scientists.
IAL understands that it is critical to stay abreast of scientific innovations and
cGMP practices so that new products can go to market cost effectively.
For this reason, our scientists routinely attend seminars and courses.
We firmly believe that we need to stay current with all technological innovations and
mandated practices so that we can truly advise our clients and we can destroy
barriers to product development.
Consequently, IAL is available for analytical consulting and we will develop methods and
the supporting validation protocols our clients require. In addition, IAL can validate
current Client methods to help ensure accuracy and reliability of those procedures.
The protocol for validations can be client supplied or based on current USP or ICH guidelines. The methods we develop use validation standards that ensure that the developed methods are rugged and robust enough to be used globally. We will work diligently to assist you in obtaining FDA approval.
All our developed methods and results are properly documented in our reports. Reports can be
customized to a client's specifications or a standard report can be issued. Standard reports
include analytical data, procedure, and supportive documentation such as chromatographs and
standards. IAL also offers a complete report writing package for inclusion in regulatory
submissions.
Analytical Services Include:
Analytical Method Development, Validation, and Transfer
Stability testing for a drug substance and drug product including impurities
Stability testing for cosmetics
Finished Product Release
Residual Solvents
Cleaning Validation
Dissolution
Photostability - Forced degradation
Analytical Techniques Employed to Develop and Validate Methods include:
High Pressure Liquid Chromatography (HPLC)
Gas Chromatography (GC)
Mass Spectrometry (GCMS)
Inductively Coupled Plasma Mass Spectrometry (ICPMS)
Flame Atomic Absorption
Spectroscopy
Dissolution
Physical testing
Please call our Pharmaceutical and Cosmetic Testing Business Development Department
at 973-361-4252 for more information regarding our method development and
validation capabilities. You can also contact us via email at
pharminfo@ialonline.com.
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