Seidlin Consulting
Seidlin Consulting LLC provides strategic consulting services to the pharmaceutical and biotechnology industry, assisting companies in planning and executing development strategies to achieve regulatory approvals, attract partners or venture capital, and create strong management structures for development programs. The company offers expertise in designing and optimizing development strategies, prioritizing drug portfolios, evaluating licensing candidates, and advising on strategic partnerships.
Industries
Nr. of Employees
small (1-50)
Seidlin Consulting
New York, New York, United States, North America
Services
Advisory services to design and optimize clinical development strategies and program-level planning across phases I–IV.
Design of trial protocols and oversight of trial implementation, including site and vendor selection and operational monitoring.
Preparation of regulatory dossiers, briefing books and support for advisory committee presentations and label negotiations.
Assessment and prioritization of development portfolios and evaluation of external candidates for licensing or investment.
Guidance on selection and oversight of contract research organizations to ensure legal and regulatory compliance of development programs.
Implementation and review of safety tracking systems, evaluation workflows for safety events, and development of medical information resources.
Advisory services to design and optimize clinical development strategies and program-level planning across phases I–IV.
Design of trial protocols and oversight of trial implementation, including site and vendor selection and operational monitoring.
Preparation of regulatory dossiers, briefing books and support for advisory committee presentations and label negotiations.
Assessment and prioritization of development portfolios and evaluation of external candidates for licensing or investment.
Guidance on selection and oversight of contract research organizations to ensure legal and regulatory compliance of development programs.
Implementation and review of safety tracking systems, evaluation workflows for safety events, and development of medical information resources.
Expertise Areas
- Clinical trial management
- Regulatory submissions and advisory committee defense
- Global clinical development organization and integration
- Clinical pharmacology and biometrics
Key Technologies
- Clinical trial design and protocol development
- Regulatory dossier preparation
- Safety tracking and pharmacovigilance systems
- Biostatistics and biometrics