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A pharma partner that can help bridge the gaps and challenges you face in completing your project and company goals

Are you looking for someone to help you through your pharmaceutical drug substance and/or drug product development and commercial phases with respect to the analytical chemistry requirements and appropriate chemistry and manufacturing controls (CMC) section of your regulatory filings?  

 

Are you trying to set up new laboratories for Analytical R&D or Quality Control (QC) activities?  Need improvements or remediation to existing laboratories?  Not sure when cGMP requirements kick in or what is required for qualification of the laboratory instrumentation?   

 

Are you outsourcing your analytical support and need someone to understand, guide and manage it?  

 

Have you received regulatory deficiencies and seem to struggle getting your products approved?  

 

Are you struggling with Out of Specification (OOS) or atypical analyses on your products and need expertise in troubleshooting problematic products, methods and/or manufacturing processes?

 

Are you in a merger or acquisition endeavor to purchase a pharma company or analytical laboratories and need help with the due diligence activities?  

 

Do you need help deciphering the analytical chemistry data associated with drug substances and/or drug products pertaining to patent litigation or lawsuits?

 

Do you have a need for a chemistry expert witness related to the pharmaceutical or fine chemical industries? 

 

Would you like someone who can convert the "high tech" science evidence to a language that non-scientific people can understand and appreciate?

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