Conventus Biomedical Solutions, Inc.
Conventus Biomedical Solutions is a private-held consulting firm specializing in development solutions and global regulatory strategies and submissions for investigational medicinal products in early development stages through Phase 3. The team includes full-time expert personnel and affiliates with deep expertise across multiple disciplines, with successful experience in various therapeutic areas and vaccine indications. The company aims to expedite the development of investigational drug products through integrated, multidisciplinary support.
Industries
Nr. of Employees
small (1-50)
Conventus Biomedical Solutions, Inc.
9920 Pacific Heights Blvd., Suite 150, San Diego, CA 92121
Products
Adenoviral vector production master file
Regulatory master file support for production of adenoviral vectors used as biologic product components.
Cell therapy and implantable device program (combination product)
Development and regulatory program support for cell therapy combined with an implantable device for treatment indications.
Gene-based therapeutic development programs
Advisory support for gene therapy programs targeting cardiovascular and hematologic indications including regulatory planning and submission support.
Recombinant protein and monoclonal antibody programs
Regulatory and development support for recombinant protein therapeutics and antibody–drug conjugate style approaches.
Vaccine program advisory (plasmid and genetically modified organism platforms)
Development and regulatory advisory for vaccines based on plasmid vectors and genetically modified organisms/parasites.
Small molecule development programs
Advisory support for small molecule therapeutic programs including target product profiling, regulatory planning, and CMC coordination.
Adenoviral vector production master file
Regulatory master file support for production of adenoviral vectors used as biologic product components.
Cell therapy and implantable device program (combination product)
Development and regulatory program support for cell therapy combined with an implantable device for treatment indications.
Gene-based therapeutic development programs
Advisory support for gene therapy programs targeting cardiovascular and hematologic indications including regulatory planning and submission support.
Recombinant protein and monoclonal antibody programs
Regulatory and development support for recombinant protein therapeutics and antibody–drug conjugate style approaches.
Vaccine program advisory (plasmid and genetically modified organism platforms)
Development and regulatory advisory for vaccines based on plasmid vectors and genetically modified organisms/parasites.
Small molecule development programs
Advisory support for small molecule therapeutic programs including target product profiling, regulatory planning, and CMC coordination.
Services
Consulting on regulatory strategy, gap analysis, target product profile development, and regulatory due diligence to support development timelines.
Preparation and compilation of regional and multinational regulatory submissions including Pre-IND/IND, CTD-format dossiers, clinical trial applications, and master files.
Due diligence audits, GLP/GMP/GCP gap analyses, QSR audits for devices, and quality system development support.
Design and oversight of PK/PD and toxicology programs, protocol development, GLP compliance oversight, and CRO selection/oversight.
CMC planning and gap analysis for biologics and small molecules, coordinated with manufacturing and technical experts.
Preparation and management support for formal regulatory interactions including FDA and EMA meetings and other agency scientific advice sessions.
Consulting on regulatory strategy, gap analysis, target product profile development, and regulatory due diligence to support development timelines.
Preparation and compilation of regional and multinational regulatory submissions including Pre-IND/IND, CTD-format dossiers, clinical trial applications, and master files.
Due diligence audits, GLP/GMP/GCP gap analyses, QSR audits for devices, and quality system development support.
Design and oversight of PK/PD and toxicology programs, protocol development, GLP compliance oversight, and CRO selection/oversight.
CMC planning and gap analysis for biologics and small molecules, coordinated with manufacturing and technical experts.
Preparation and management support for formal regulatory interactions including FDA and EMA meetings and other agency scientific advice sessions.
Expertise Areas
- Regulatory strategy and global submissions
- Clinical development planning (Phase I–III)
- CMC planning for small molecules and biologics
- Quality assurance and compliance (GLP/GMP/GCP/QSR)
Key Technologies
- Cell and gene therapy
- Recombinant protein therapeutics
- Monoclonal antibody therapeutics
- Adenoviral vector production
News & Updates
Overview of recent projects in various therapeutic areas including endocrine, dermatology, cardiovascular, hematology, oncology, and infectious disease vaccines.
Overview of recent projects in various therapeutic areas including endocrine, dermatology, cardiovascular, hematology, oncology, and infectious disease vaccines.