Conventus Biomedical Solutions, Inc

CONVENTUS BIOMEDICAL SOLUTIONS, INC. is a privately-held, expert-level consulting firm specializing in regulatory strategies and requirements for biopharmaceutical products in early development stages through Phase 3. The Conventus team maintains offices in the Sorrento Valley area of San Diego and is led by Mr. Steven Kradjian, a Senior Regulatory Affairs professional who has led 27 successful IND filings at Conventus. Conventus’ recent experience includes two biologics INDs in cardiovascular disease indications, and deep experience from planning the regulatory approach to expedite prudent development of biological and pharmaceutical products, to planning, writing, and filing these INDs with no clinical holds. In addition, Conventus has deep and recent experience working with FDA to address and resolve CMC issues for biological products in lyophilized dosage forms, mid-development formulation changes, potency method development for rDNA proteins, and negotiating carcinogenicity, pharmacology and toxicology requirements with FDA. SERVICES OFFERED • Global Regulatory Management • Quality Assurance/Change Control • CMC Biologics and Small Molecules • Pharmacology (PK/PD)/Toxicology Planning and Oversight • Clinical Operations • Regulatory Strategies for Biosimilars • Regulatory Strategies for Combination Products