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Company Profile


PharmaDirections, Inc. 

5001 Weston Parkway
Suite 103
Cary  North Carolina  27513  U.S.A.
Phone: 919-657-0660 Fax: 919-573-9318


PharmaDirections, Inc. is a senior scientific team with deep industry knowledge and experience, leading six targeted domains, ensuring quality at every step and shaping our engagement to meet your exact needs. A flexible global network of expert, audited resource providers, available as needed to support your drug development objectives with precisely the right services at the right time.

Technical Services:

  • PreIND
  • Candidate selection
  • Pivotal Pharmacology
  • Initial safety evaluation
  • Initial CMC due diligence
  • IND Enabling
  • Pharm/Tox
  • Bioanalytical method development
  • Safety Pharmacology
  • Toxicology
  • CMC
  • Analytical method development
  • Drug substance
  • Formulation
  • Drug Product
  • Regulatory Affairs
  • IND preparation/submission
  • Quality assurance
  • Phase 1-2 Development
  • Pharmacology/PK
  • Study design
  • PK analysis
  • Clinical Trial Materials
  • CTM Manufacturing
  • Packaging, labeling & Distribution

    Markets Served:

  • PreIND
  • IND Enabling
  • CMC
  • Regulatory Affairs
  • Phase 1-2 Development
  • Clinical Trial Materials

    Major Products/Services:

    Strategic Planning tailored to your specific products and goals with individualized product development plans for critical development path for your product. Candidate Selection and IND Enabling Pharmacology and Toxicology to provide the shortest most optimal path to candidate selection, leading experts and sound project management to execute an efficient and sound Pharm/Tox program. IND Enabling CMC and Phase 1 PK. Regulatory Affairs and Quality Assurance experts are an integral part of the team from the inception of your project. Phase 1-2 Clinical Trial Material including our proprietary electronic manufacturing execution system for on-demand capacity to support global clinical trial requirements.

    Key Contact:

    Thomas J. Colatsky, Ph.D.
    Practice Head, Preclinical Development
    Office: (919) 657-0704

    Rick Soltero, Ph.D.
    Office: (919) 657-0701

    Key Statistics

    Ownership: Private

    Web Site: PharmaDirections, Inc.
    Employees: 70+ Internal/External

  • Company News
    Alte Biosciences to Present Depression and Gastrointestinal Disorder Treatments at 2008 SEBIO10/9/2008 2:34:50 PM
    PharmaDirections, Inc. Invents Unique Packaging for Pharmaceutical Products 7/16/2008 11:24:01 AM
    PharmaDirections, Inc. Release: PathfINDAr(TM): A Revolutionary Tool for Building Pathways to an IND and NDA 3/27/2008 9:08:17 AM
    PharmaDirections, Inc. Launches PHARMADIRECTNET(TM) 3/12/2008 9:55:20 AM
    PharmaDirections, Inc. Names Dr. Steven Gordziel as Practice Head 2/21/2008 11:25:57 AM
    PharmaDirections, Inc. Names Fred Pruden as Practice Head 11/12/2007 10:13:07 AM
    PharmaDirections Names Dr. Thomas Colatsky As Practice Head 5/17/2006 1:50:14 PM
    PharmaDirections Appoints Barrett As Controller 11/29/2005 10:25:08 AM
    PharmaDirections President Richard Soltero To Discuss Issues And Case Studies Of Virtual CROs10/19/2005 5:12:35 PM
    BioSpace Releases Its 3rd Edition Of Bio NC™ 10/19/2005 5:12:33 PM