Conventus BioMedical Solutions, Inc.
is an integrated, multi-disciplinary senior consulting firm capable of expediting the development of investigational new drug products.
PRODUCT DEVELOPMENT PLANNING
Strategic Planning
- Regulatory Gap Analysis
- Target Product Profile
- Risk Assessment Supporting Expedited Development Pathways
- Regulatory Due Diligence
Integrated Developement Planning
- 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)
GLOBAL REGULATORY MANAGEMENT
Submission Preparation
- 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
Meetings with Regulatory Agencies – Planning and Meeting Management
- 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
QUALITY ASSURANCE
Due Diligence Audits: Gap Analysis and Compliance Assessments
- GLP, GMP, GCP in U.S., and ICH Regions
- QSR for Class II and Class III devices
- Quality System Development and Gap Analysis
PHARMACOLOGY/TOXICOLOGY
Pharmacology (PK/PD)/Toxicology planning and oversight
- Protocol development
- CRO Selection, oversight
- GLP compliance and audits
- Report preparation and oversight
