Our team of pharmaceutical experts provides regulatory and development task outsourcing alternatives for drug and biotechnology Clients of all sizes, as well as comprehensive project planning and management services to help them meet their business objectives and enhance the value of their technologies.
The Anson Group has experience to provide consulting for a wide variety of regulatory activities across the continuum of drug development including:
- Preparing Briefing Documents and readying project teams for FDA meetings, such as pre-Investigational New Drug (pre-IND), End-of-Phase 2, pre-New Drug Application (pre-NDA), and pre-Biological License Application (pre-BLA) meetings
- Preparing IND, NDA and BLA annual reports
- Preparing and reviewing Investigator’s Brochures (IB) – pre-clinical and clinical information serving as labeling for investigational drugs or biologics
- Training on Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices, (GMP)
- Investor advisory services
- Due diligence projects to provide advice to investors or venture capital groups
Anson has experience with a variety of regulatory mechanisms to enhance drug development and will advise Clients when appropriate on the possibility of seeking, for example, Orphan Drug designation, Fast Track designation, Accelerated Approval, and Priority Review.
Anson consults at any and all stages of pharmaceutical development. Listed below are services representative of the types available at each stage:
Non-Clinical/Pre-Clinical Testing (Prior to submission of IND) Click to expand +
Purpose: To assess safety and viability of new molecular entities (NMEs) or therapies
Anson supports:
- Overall development program strategy and design
- Active Pharmaceutical Ingredient (API) synthesis and purification consultation
- Formulation development consultation, including vendor selection for formulation preparation
- Review of compound toxicology profile to determine ‘IND-readiness’
- Toxicology support. Review and commentary on toxicology study data, including advice on additional studies that may be required
- Critical supplier selection for study sites to conduct toxicology studies
- Preclinical study site selection
- Study monitoring
Filing the IND: Click to expand +
Purpose: To successfully complete the 30-day regulatory waiting period and proceed with clinical testing
Anson supports:
- Reviewing and conducting gap analysis on data and commentary to determine if additional data may be needed before filing the IND
- Establishing contact with key FDA personnel before IND submission
- Preparing Pre-IND Briefing Document, scheduling and conducting pre-IND Meeting with FDA
- Analyzing FDA comments from the pre-IND Meeting and any additional studies proposed/required by FDA resulting from that meeting
- Preparing and reviewing IND submission documents, including the Investigator’s Brochure (IB)
- Reviewing IND for completeness and accuracy
- Submitting the initial IND and IND amendments (subsequent documents) to FDA
- Providing advice regarding appropriate responses to FDA questions or concerns
Phase 1 Studies: Click to expand +
Purpose: To determine initial clinical safety profile and preliminary dosage levels
Anson supports:
- Coordination of FDA meetings
- Clinical program development, including:
- Protocol design
- Critical supplier selection for clinical studies
- Clinical investigation site selection
- Clinical investigation site auditing and compliance review
- Investigational Review Board (IRB) review
- Updating the IB as new pre-clinical and clinical information becomes available
Phase 2 Studies: Click to expand +
Purpose: To evaluate effectiveness and observe adverse reactions (drug ‘side effects’)
Anson supports:
- Coordination of FDA meetings
- Clinical program development, including:
- Protocol design
- Critical supplier selection for clinical studies
- Clinical investigation site selection
- Clinical investigation site auditing and compliance review
- Investigational Review Board (IRB) review
- Updating the IB as new pre-clinical and clinical information becomes available
- Development of API manufacturing process
- Development of formulation manufacturing process
Phase 3 Studies: Click to expand +
Purpose: To confirm/verify effectiveness, monitor adverse reactions
Anson supports:
- Coordination of FDA meetings
- Clinical program development, including:
- Protocol design
- Critical supplier selection for clinical studies
- Clinical investigation site selection
- Clinical investigation site auditing and compliance review
- Investigational Review Board (IRB) review
- Updating the IB as new pre-clinical and clinical information becomes available
- Development of API manufacturing process
- Development of formulation manufacturing process
- Clinical trial monitoring
- Transfer to manufacturing
- Consultation on material supply– both API and formulations
- Process optimization
- Assistance in preparing protocol submissions for Special Protocol Assessments
- Compiling IND Annual Reports, including writing and submission
Filing the NDA/BLA: Click to expand +
Purpose: To obtain FDA approval to market new drug or biologic product
Anson supports:
- Preparing and reviewing NDA/BLA documents for completeness and accuracy
- Development of regulatory response database to track FDA queries and sponsor responses
- Finalizing the Draft Label
- Preparing and reviewing the NDA/BLA dossier
- Submitting the NDA/BLA
- Preparing development team for Advisory Committee hearings
- Evaluation of manufacturing and clinical investigation sites (BiMo audits) for acceptable Pre-Approval Inspection (PAI) by FDA
Phase 4 Post Marketing Requirements and Other Post Marketing Activities: Click to expand +
Purpose: To maintain compliance with FDA manufacturing requirements and FDA post-marketing commitments
Anson supports:
- Development of post-marketing regulatory strategy to handle:
- Product recalls
- FDA inspections
- FDA 483 responses
- FDA Warning Letter remediation
- Tracking NDA/BLA post-marketing commitments
- Optimization of the quality system
- Clinical trials to support label expansion for additional indications
- Submission of Label changes
- Compiling and submitting NDA/BLA Annual Reports
- Compiling and submitting data to support provision of Pediatric Exclusivity to extend marketing exclusivity
