신약 개발 컨설팅

Services

Regulatory Strategy

Novotech Drug Development Consulting can act 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, TGA, 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, TGA, and EMA Meetings and Filings
• Scientific Advice
• Risk Management and Due Diligence
• OGTR/EPA Licenses for GMO Products
• Institutional Biosafety Committee (IBC) Support

CMC and Product / Analytical Consulting

Novotech Drug Development Consulting offers 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 and Nonclinical (Toxicology/Pharmacology) Consulting

We can develop Clinical Development Plans (CDP) and all clinical study documents. 

• Medical and Clinical Program Strategy
• Clinical Development Planning
• Proprietary "Real Time" Audit Services

Our nonclinical services include planning and designing studies, selecting contract laboratories, and evaluating study conduct, data, and final reports.

• Oversight for Nonclinical and Toxicity Studies
• Design and Review GLP-Compliant Toxicology Studies in Support of Human Studies and Marketing Approval

Quality / GMP / CMC 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
• Experienced in Building QA Systems for Biotechs and Start-ups
• Experts in Biological CMC

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, utilizing state-of-the-art software solutions to deliver compliant e-submission 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

Accomplishments for Our Clients in the Last 5 Years:

• Assisted or published 23+ INDs, 16 with a major role
• Authored and submitted 6 Orphan Drug Designations and Master Files
• Supported 3 NDAs/ANDAs and 2 BLAs
• US Regulatory Representative or US Agent for 18 dossiers currently and 51+ in the last 5 years (INDs, pre-INDs, NDAs, BLAs, and Orphan Drug Designations)
• Conducted 67+ FDA meetings/teleconferences or WRO
• Complete 250+ submissions to regulatory authorities per year