Preclinical Drug Development Consultants

What we offer:

Many small biotech or pharmaceutical companies have the research capabilities to develop new molecules, but lack the knowledge or expertise to move them into human clinical trials, and ultimately, to have their product registered for sale.

PharmOut provides management and implementation services and expertise in the following areas -

Drug Candidate Selection
Preclinical programs to support clinical trials and product registration

Drug candidate selection

We can assist with:

Preparation of strategy documents
Lead Drug Optimisation and Drug Candidate Selection
Clinical Research Organisation (CRO) selection
Contract management
Project management
Protocol development and review
Report review
Chemical scale up facilities

Preclinical Program

Organise and manage preclinical development programs.

Once a drug development candidate is selected this service develops and manages the appropriate preclinical safety evaluation program to support the conduct of clinical trials and drug registration.

We can assist with:

Preclinical strategy recommendations
Toxicology program design
Clinical Research Organisation (CRO) selection
Contract management
Project management
Study protocol development and review
Study monitoring
Report review

Regulatory Authority Interface

Knowledge of preclinical regulatory guidelines
Resolve regulatory issues
Provide representation at Local and Overseas regulatory meetings
Evaluation of nonclinical dossiers for completeness prior to submission to a regulatory authority