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CONTRACT DEVELOPMENT AND MANUFACTURING OPERATIONS (CDMO)

Whether you are a contract development and/or manufacturer, or a company looking to contract services in the pharmaceutical sector, Cooney Pharma Consulting, LLC can provide expertise and guidance for your analytical and associated CMC activities.   Rita  has directed analytical organizations at CDMO companies  that are involved in the development of Active Pharmaceutical Ingredients (API) and dosage-form drug products.   She has also dealt with numerous clients and regulatory agencies in getting products through their intended regulatory filing and approval.  Her knowledge and insight as to how CDMO's operate and function can be valuable if you are looking to start your own CDMO or partner with one.   

Looking to partner with a CDMO or CRO?

 

  • Assess analytical laboratories and capabilties

  • Assess staffing and technical competencies

  • Provide guidance and oversee the analytical method development and support for API and/or drug product development

  • Oversee and coordinate stability programs

  • Review analytical data generated

  • Author CMC analytical sections for regulatory filings

  • Review OOS or atypical investigations and associated CAPA's

  • Review new business proposals from CDMOs

Is your company a CDMO or CRO?

 

  • Provide guidance and/or leadership to your analytical laboratories

  • Assess current organizational structure and technical competencies

  • Provide guidance for stability and reference standard programs

  • Help with OOS or atypical investigations and associated CAPA's

  • Assess analytical capabilities versus business needs

  • Help structure analytical requirements and quotes in client proposals

  • Provide guidance on phase-appropriate analytical requirements

  • Provide guidance on cGMP laboratory requirements

  • Work with your Business Development staff

  • Partner with you on responding to clients or regulatory agencies

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