Our team of toxicologists, chemists, pharmacologists, and regulatory affairs professionals work closely to move projects from conception to approval. We currently manage INDs for more than 50 clinical trials for both government and private clients. A number of the studies we manage are considered registration studies by our pharmaceutical partners.
We offer extensive experience working with FDA, Health Canada, and other international regulatory agencies. Our team of scientists and medical writers produce regulatory submissions that are compliant with worldwide regulatory requirements and ICH guidelines.
As well as regulatory experience in drug products for cancer chemoprevention and treatment, our specific capabilities include botanicals, dermatologic, neurologic, hormonal, gastrointestinal, hematologic, urologic, and imaging studies.
We offer:- Regulatory intelligence
- Strategy consultation
- Representation with regulatory authorities
- Meeting management
- Scientific writing to support clinical trial submissions
- Expert review of chemistry, manufacturing and controls (CMC), nonclinical, clinical, and safety data
- Special expertise on botanical drug development issues
- Preparation of SOPs
- Charter review and interface with Data Safety Monitoring Committees
- Consultation for federally funded clinical studies, including OHRP Assurance
- Protocol development, both in concept and design, preparation, and review
- Project management
- Regulatory document collection, review, and maintenance throughout the study lifecycle
- IC design/review by certified IRB professional
- Clinical trial report review and preparation, including final reports
- INDs (includes eCTD format)
- NDAs (includes eCTD format)
- ANDAs
- CTAs
- DMFs
- Orphan Drug Designations
- Publications
- Literature Reviews