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“Experience is the child of thought, and thought is the child of action.”  Benjamin Disraeli

Services

MfgVialsTracy BioConsulting, LLC offers the following services tailored to the individual needs of each client, to effectively drive biomedical platforms and programs into and through the clinic.

Product Development and Technical Services

  • Developing and implementing plans to bring new platform technologies and drug programs from preclinical research stages through successful regulatory filings and into the clinic, utilizing:
    • Product development expertise including support for scale-up, GMP manufacturing, and successful regulatory filings
    • Connections with an extensive network of CROs and CMOs
    • Program management support to ensure integration of program activities and collaborators
  • Providing scientific and technical expertise in the development of:
    • RNA and other nucleic acid based products
    • Nanotechnology-based products
    • Protein, peptide, and small molecule-based products utilizing novel delivery approaches

Partnerships and Alliance Services

  • Support in forging and nurturing effective CMO/CRO relationships
  • Assistance with the establishment of new business partnerships and collaborations as well as management of these relationships to achieve the program goals
    • Access to broad network of major biopharma companies.

Business Development Services

  • Identification of new business opportunities and approaches to create enhanced value for technology platforms
  • Leading or supporting technology assessment and due diligence activities
BioConsulting Briefs
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Mark Tracy Receives CRS Distinguished Service Award
Mark A. Tracy was awarded the prestigious Distinguished Service Award of the Controlled Release Soci ( Read More )
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Interview with Mark Tracy
Insights into the Biopharmaceutical Industry ( Read More )
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Interspecies information website
This website is an excellent resource for physiological, anatomical and biochemical parameters for a ( Read More )
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Good review practices for INDs
A helpful new FDA document was recently issued describing the FDA’s good review practices for ( Read More )
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Approval of Kynamro
The January 2013 approval of Kynamro (mipomirsen) marks the first systemically administered antisens ( Read More )