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
  • Strategic Planning
  • Regulatory Gap Analysis
  • Target Product Profile
  • Risk Assessment Supporting Expedited Development Pathways
  • Regulatory Due Diligence
  • Integrated Development 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 (PK/PD)/Toxicology planning and oversight
  • Protocol development
  • CRO Selection, oversight
  • GLP compliance and audits
  • Report preparation and oversight
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