Our Services
At Conventus Biomed, we don’t just provide services—we architect smarter development pathways. Whether you're advancing a novel biologic, mRNA vaccine, small molecule, or cell therapy, our expert consultants integrate scientific strategy, regulatory foresight, and quality execution to keep your program on track and ahead of the curve.
We combine deep technical knowledge with the agility your team needs to move fast—without compromising quality or compliance.
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
Let’s Build Something That Lasts
Whether you're preparing your first IND or planning a global Phase 3, Conventus Biomed brings the insight, speed, and experience to help you deliver.