What Can We Do For You?
Novotech Drug Development Consulting is a full-service global product development, clinical oversight, and regulatory operations group providing comprehensive "lab to launch" program development services. We have a proven track record of successful FDA meetings and approvals. Our teams have the expertise to support your projects over their entire lifetimes, all the way from preclinical development through approval and post-marketing.
We serve the biotechnology, pharmaceutical, and device industries worldwide. Our expert staff is experienced in an all-encompassing range of indications for drugs, novel antibodies, recombinant protein therapeutics, small molecules, vaccines, cell therapy, devices, and combination products, throughout all phases of program development (Phases I - IV) and commercialization.
We are currently assisting clients with COVID-19 development programs and we are very familiar with the FDA's Coronavirus Treatment Acceleration Program (CTAP). We are assisting clients through this process to accelerate products to the clinic. Please contact us if you need assistance or general advice: call us at 720-746-1190 or email info@cbrintl.com.
Regulatory Strategy
We can serve as your Authorized Representative to the FDA and will take on responsibility for successful interactions with the Agency. We also offer strategic and tactical planning for FDA and EMA interactions.
- US Regulatory Representation (FDA - CBER, CDRH, CDER)
- Design of Integrated Regulatory, Scientific, and Clinical Strategies for Global Product Development
- Experts in Conducting FDA and EMA Meetings and Filings
- Scientific Advice
- Risk Management and Due Diligence
Product / Analytical Consulting
We offer scientific review of processes, programs, and testing, as well as design of pilot, validation, and tech transfer programs to support regulatory filings worldwide.
- Product, Process, and Method Development and Validation Strategy
- Technical Writing and Data Review
- Regulatory Positioning
- On-site data management
Clinical / Nonclinical Consulting
We can develop Clinical Development Plans (CDP) and all clinical study documents. We also offer "Real Time" oversight of studies. Our nonclinical services include planning and designing studies, selecting contract laboratories, and evaluating study conduct, data, and final reports.
- Medical and Clinical Program Strategy
- Clinical Trial Oversight and Clinical Development Planning
- Oversight for Nonclinical and Toxicity Studies
- Proprietary "Real Time" Audit Services
Quality / GMP Consulting
We are experienced in development of QA systems and cGMP compliance programs. We also offer oversight of manufacturing and testing, and can conduct due diligence of CMOs.
- Experts in cGMP Compliance
- Extensive Experience in Design and Oversight of Quality Systems
- On-Site Mock Audits/PAIs
Electronic Submissions
We have over 15 years of experience in electronic submissions to the FDA and other regulatory authorities around the globe. We provide tailored services to meet client needs, and utilize state-of-the-art software solutions to deliver compliant eSubmission documents.
- Electronic publishing and lifecycle management services
- Global filing capabilities to manage multi-country submissions
- Strategic guidance to ensure a streamlined, end-to-end submission process
- Customized training for program implementation and best practices
What We Accomplished for Our Clients in the Last 5 Years:
- U.S. Regulatory Representative or U.S. Agent for 51 dossiers (INDs, pre-INDs, NDAs, BLAs, and Orphan Drug Designations)
- Significant authorship/review of 8+ INDs
- Authorship and submission of 6 Orphan Drug Designations and Master Files
- Supported 2 BLAs and 3 NDAs/ANDAs
- Conducted 76+ FDA meetings/teleconferences or WRO
- Complete 250+ submissions per year to regulatory authorities