Study Design and Management​

• Design GLP and Non-GLP studies to meet customer goals and minimize cost

• Identify CROs and compare quotes/bids

• Collaborate with study director and CRO 

• Monitor studies (on-site and day to day) 

• Review and write study reports

• Experience with general toxicology, as well as reproductive, carcinogenicity, and mechanistic toxicology studies

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Author Regulatory Submissions

• PreINDs and INDs

• BLAs, NDAs, MAAs, CTAs, and IMPDs

• Carcinogenicity and Reproductive Toxicity Waivers

• ECAC Special Protocol Assessments

• Investigator Brochures (IBs)

• Expert reviews/reports

• White Papers

• QC documents ​​

Weight-of-Evidence (WoE) Risk Assessments and Waivers

• Toxicology risk assessments for drugs, excipients, impurities and degradants; PDE, OEL determination

• Generation of expert reports

• Target liability assessments

• WoE and waivers for carcinogenicity and reproductive toxicity studies​​

Toxicology Representation

• Team meetings

• Management reviews

• Investor or board meetings

• Regulatory meetings (FDA and regulatory authorities world wide)​​

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Due Diligence

• Critical review of nonclinical data packages for in-licensing opportunities

• Gap analysis of nonclinical programs

• Third party expert reports on early-stage drug candidates

• Nonclinical strategy ​​​

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Toxicology Support for CMC/Manufacturing

• Safety Data Sheet (SDS) generation and review (GHS and/or CLP)

• Material estimates and projections for study needs

• Risk assessment for identified impurities or changes during scale-up​

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