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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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| Click here to view recent projects |
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| Product Development Planning |
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- Regulatory Gap Analysis
- Target Product Profile
- Risk Assessment Supporting Expedited Development Pathways
- Regulatory Due Diligence
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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)
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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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| Copyright@2011 Conventus BioMedical Solutions, Inc. |
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