Strategic Planning

• Integrated development plans incorporating non-clinical, clinical, and regulatory strategies
• Global strategies to optimize development timelines and commercial value
• Product strengths and weaknesses identification (i.e. risk assessment) to leverage expedited development pathways and contingency plans
• Project management functions to ensure timely and quality execution of development plans

Preclinical Safety Evaluation

The purpose of preclinical safety evaluation studies is to determine the safety margin between the no-effect dose and adverse-effect dose. This enables us to work with the clinicians to select the safe starting dose for first administration to man. In addition, these studies identify target organ toxicity, reversibility, and safety pharmacology parameters for clinical monitoring.

RTS designs preclinical programs based upon the intended clinical application. Important factors include:

• target therapeutic area
• pharmacological activity
• intended duration of treatment
• target patient population, route of exposure
• pharmacokinetics/bioavailability
• bio-markers

Preclinical safety evaluation is subdivided into two phases:

Toxicology

Test species are chosen based upon relevant science including species specificity, specialized models, route of administration, blood volume, body weight, drug availability, etc. All animal studies are conducted in AALAC accredited facilities. Sample preparation is performed according to internal SOPs and in accordance with Good Laboratory Practices. Quality systems ensure data integrity.

• IND enabling toxicology program design
• GLP laboratory identification
• Conduct of studies monitoring
• Online project management and tracking; near real-time availability of study results
• Final reports and IND summaries

Histopathology

Quality systems ensure data integrity.

• GLP histology lab
• Board-certified veterinary pathologists
• Quick turnaround times
• Peer review

Regulatory Expertise

Knowledge of the regulatory requirements and integrating these milestones into your development program will result in timely production of successful IND submissions. RTS can assist your company with:

• FDA liaison services
• Regulatory submissions preparation, including pre-IND meeting packages, IND, BLA, NDA, and related supplements/amendments
• Report writing
• Investigator brochures
• Orphan Drug and Fast Track applications