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| Conventus BioMedical Solutions, Inc. is an integrated, multi-disciplinary senior consulting firm capable of expediting the development of investigational new drug products. |
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| Product Development Planning |
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- - Target Product Profile
- - Risk Assessment Supporting Expedited Development Pathways
- - Regulatory Due Diligence
- - Orphan Development, Accelerated Approval and 505(b)(2) NDA
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- Integrated Development Planning
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- - Regulatory Plan and Gap Analysis
- - Clinical Plan and Gap Analysis
- - Non-clinical Development Plan and Gap Analysis
- - CMC Development Plan and Gap Analysis (Small Molecule and Biologics)
- - Special Protocol Assessments
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Global Regulatory Management |
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- - Pre-IND, IND, Common Technical Document Format
- - Clinical Trial Applications, Investigational Medical Product Dossiers
- - Expertise in Cellular and Gene Therapy Submissions
- - Drug and Biologic Master Files
- - Technical Writing and Professional Word Processing
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- Meetings with Regulatory Agencies – Planning and Meeting Management
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- - FDA Meetings Type A, B, and C
- - EMEA Scientific Advice Meetings
- - Pre-IND, IND, End of Phase II, pre-NDA/BLA, Advisory Committee Meetings, Labeling
Meetings
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Quality Assurance |
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- Due Diligence Audits: Gap Analysis and Compliance Assessments
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- - GLP, GMP, GCP in U.S. and ICH Regions
- - QSR for Class II and Class III devices
- - Quality System Development and Gap Analysis
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| Pharmacology/Toxicology: |
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- Pharmacology (PK/PD)/Toxicology planning and oversight
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- - Protocol development
- - CRO selection, oversight
- - GLP compliance and audits
- - Report preparation and oversight
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Clinical Operations: |
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- Clinical Program Strategic Development and Protocol Design
- Biostatistical Evaluation of Clinical Trial Design
- Preparation of Integrated Clinical and Statistical Reports
- Investigator Selection/ Site Initiation
- Biostatistical Analysis of Clinical Trial Data
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| Copyright@2007 Conventus BioMedical Solutions, Inc. |
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