Global BioDevelopment has a team of top Board Certified Toxicologists who are available to serve as consultants for pharmaceutical development programs. Our toxicology consultants will assist our clients in creating the right path through the preclinical development process. Global BioDevelopment’s clients rely on us to help them choose and design the appropriate studies, interact with the FDA, maximize budgets, choose the right CROs, manage/monitor the process, write the Investigator’s Brochure, and prepare and file the IND.
Therapeutic areas of expertise include oncology, anti-infectives, endocrinology, CNS, cardiovascular and inflammation. Our experience covers small molecules, recombinant proteins, monoclonal antibodies, oligonucleotides, liposomal formulations and cancer vaccines.
Our toxicologists will design and manage IND enabling preclinical development programs including in-vitro models, pharmacology/efficacy studies, safety pharmacology, toxicokinetics (TK), genetic toxicology studies, metabolism studies, acute and repeat dose safety studies.
Later stage NDA required programs, including chronic toxicology studies, reproductive toxicology studies, genetic toxicology/mutagenicity studies, carcinogenicity studies, drug – drug interaction studies are also managed by our consulting toxicologists.
Regulatory submissions for INDs or NDAs are written in either paper or eCTD format. We also have expertise submitting regulatory documents to European, Japanese, Australian and New Zealand agencies.
Global BioDevelopment’s toxicologists are experienced in conducting due diligence assessments for product valuation.