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
Company Details
- Employees
- 6
- Founded
- -
- Address
- 5414 Oberlin Dr., Ste. #130, San Diego,california 92121,united States
- Phone
- (858) 401-2111
- ad****@****med.com
- Industry
- Biotechnology
- Website
- conventusbiomed.com
- Keywords
- Regulatory Affairs Consulting, CMC Biologics and Small Molecules, Quality Assurance/Change Control, Pharmacology (PK/PD)/Toxicology Planning and Oversight, Clinical Operations, Management Consulting, Regulatory Strategies for Biosimilars and Combination Products.
- HQ
- San Diego, California
Conventus Biomedical Solutions, Inc. Questions
Conventus Biomedical Solutions, Inc.'s helpline number is (858) 401-2111
Conventus Biomedical Solutions, Inc.'s website is conventusbiomed.com
Conventus Biomedical Solutions, Inc.'s LinkedIn profile is https://www.linkedin.com/company/conventus-biomedical-solutions-inc-
Conventus Biomedical Solutions, Inc. has
6 employees.
View email and phone details for 6
employees at Conventus Biomedical Solutions, Inc..
Conventus Biomedical Solutions, Inc.'s industry is
Biotechnology
Conventus Biomedical Solutions, Inc.'s top competitors are
Marketing Endeavors Strategic Consulting,
Vertex Pharmaceuticals,
Beigene,
Biomedical Solutions,
Viscient Bio Inc,
Amigo,
Biomarin Pharmaceutical Inc.,
Japanese Medical Care,
Sage Therapeutics,
Puma Biotechnology, Inc..
Conventus Biomedical Solutions, Inc.'s support email address is admin@conventusbiomed.com
Conventus Biomedical Solutions, Inc.'s categories are Biotechnology
Conventus Biomedical Solutions, Inc.'s founding year is 2005
