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
ADME/PK
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
tcolatsky@PharmaDirections.com
Office: (919) 657-0704
Rick Soltero, Ph.D.
President
rsoltero@PharmaDirections.com
Office: (919) 657-0701