Pharmaceutical Product Development
& Consulting Services
We work with you to find creative and flexible approaches to advance your clinical research goals within ethical, scientific and regulatory parameters.
Here are some of the many services we provide.
Please contact us if you don’t see the service that meets your needs, so that we can discuss your specific needs.
FDA regulated product-specific consultations
- Develop clinical research design strategies at all phases of investigation
- Provide advice on clinical trials involving cutting-edge or novel therapies, complex scientific and/or regulatory issues
- Help prepare for FDA advisory committee meetings
- Help prepare for Sponsor: FDA meetings
- Optimize regulatory communications
Bioethics consultations
- Develop clinical research design strategies for settings with unique ethical issues
- Provide advice on ethical issues related to cutting-edge or novel therapies, complex scientific and/or regulatory issues, and vulnerable populations
- Review protocols, informed consent documents, and other supporting materials for an IRB and FDA submission
- Serve as a bioethics expert on a protocol review committee or data monitoring committee
Policy development
- Develop policies and procedures for human research protection programs, institutional review boards, hospitals, and clinical ethics committees
- Assist clients in product-specific as well as broad interactions with FDA
Regulatory advice and compliance
- Provide scientific and ethical advice that is compliant with federal guidances, regulations and statutes
- Propose the least burdensome approach to appropriately protecting the rights, safety, and welfare of research participants and the scientific integrity of the research data
- Propose innovative solutions to complex scientific, legal-regulatory, and ethical concerns
- Optimize structure, function, and regulatory compliance of human research protection programs and institutional review boards
- Assist in responding to Food and Drug Administration 483 observations and Warning Letters, and Office for Human Research Protection Determination Letters
Education and training
- Provide training and education for institutional officials, members of human research protection programs, institutional review boards, investigators, research staff, clinicians, hospital staff, and clinical ethics committees
- Present on a wide array of topics including clinical trial designs, regulatory compliance, research that poses challenges such as rare diseases, emergency care, and research involving vulnerable populations (e.g., pregnant women, children, and individuals with impaired decision-making)
Due diligence
- Analysis of pharmaceutical product development for investment community
