Novotech Drug Development Consulting
Novotech Drug Development Consulting (DDC) is a full-service global product development and strategic regulatory group providing comprehensive "lab to launch" program development services, including regulatory strategy and operations, CMC and product/analytical consulting, clinical oversight, toxicology and other nonclinical consulting, quality / GMP consulting, and electronic submissions. We have a proven track record of successful FDA meetings and approvals. Our teams have the expertise to support your projects over their entire lifecycle, all the way from preclinical development through to 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.
What We Do: Our Strategic Team Approach
The DDC team is dedicated to providing comprehensive product development services. We work with clients to identify program pathways and strategies. We know that identifying goals and gaps, and asking the right questions, will result in cost-effective and timely product development.
We take a thoughtful, measured, and dedicated approach to every client program. Our scientific, non-clinical, clinical, and program development expertise has resulted in numerous biotech, drug, and device approvals through FDA and other global regulatory authorities.
What Makes Us Different: Our Core Principles
Our work is based around these core principles:
- We assist companies with strategic development of novel biotechnology and pharmaceutical products as a development partner.
- We strive to create an environment of learning and professional development.
- We promote team-building within projects and programs, to better advance client goals and long-term staff development for our clients and for our own staff.
The Novotech Drug Development Consulting team is unique in that we embrace a team concept that extends beyond our own staff. For example, we include experts in various disciplines and work with our global partners to achieve the highest effectiveness. Most importantly, our team members integrate into client programs to become part of the client team and drive programs to success. Our team model provides for full awareness of program needs, appropriate expertise, knowledge redundancy, reduced costs, and highly-effective results. We strive for excellence and achieve client goals in every project.
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
Drug Development Planning
Starting Your Journey with the End in Mind – the Value of a Development Plan
Novotech Drug Development Consulting (DDC) can help you establish an intelligent product development program for your drug, biotech, device, or other product. A robust development plan is vital for clarity around the complex processes required to achieve product approval. With the DDC team’s expertise and experience, we can help identify ways to accelerate development and approval from the beginning of the process.
The product development plan informs every part of the journey throughout all phases of program development (Phases I - IV) and commercialization, including research partners and locations, regulator engagement, timelines, budgeting, capital-raising, staff hires, and much more.
The planning process cuts risks, including unexpected regulatory hurdles and costs, and ensures that the development program’s progress aligns with investor expectations, as well as optimising resources throughout the development program.
The development plan also covers any CMC and quality requirements, non-clinical animal studies and other requirements, and the type and scope of clinical studies that may be needed to support product registration. In addition to the typical clinical Phase I, II, and III program, the development plan can highlight any additional studies or other requirements that might be needed to support the application.
Novotech Drug Development Consulting (DDC) can provide expert strategic advice and services across all aspects of product development. With the DDC team’s expertise and experience, we can help identify ways to accelerate and optimise the product development process.