Novotech Drug Development Consulting

Novotech Drug Development Consulting is a full-service global product development and 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

We are dedicated to providing comprehensive product development services to the biotechnology, pharmaceutical, and device industries worldwide. 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.

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. 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.

Our focus:

1. To assist companies with strategic development of novel biotechnology and pharmaceutical products as a development partner.
2. To create an environment of learning and professional development.
3. To 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.

We take a thoughtful, measured, and dedicated approach to every client program.

What Makes Us Different

We are unique among consulting organizations 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 Page

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 support (IBC)

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 client’s GLP-compliant toxicology studies in support of human studies and marketing approval.

Quality / GMP Consulting / CMC

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
• Experts in biological CMC
• Experienced in building QA systems for biotechs and start-ups
• 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, 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 2 Years:

• Currently U.S. Regulatory Representative or U.S. Agent for 23 dossiers (INDs, pre-INDs, NDAs, BLAs, and Orphan Drug Designations)
• Submitted 9 original applications: 1 BLA, 5 INDs, 1 Orphan Drug Application, 2 Master Files
• Completed 900+ submissions to regulatory authorities
• Attended 11 FDA meetings
• Supported 32 clinical studies

Drug Development Planning 

Starting Your Clinical Journey with the End in Mind – the Value of a Drug Development Plan

Establishing an intelligent clinical development program pathway from the start is vital for clarity around the complex processes required to achieve product registration.

The Drug Development Plan (DDP) plan informs every part of the journey from budgeting, capital-raising, timelines, clinical phases, research partners, research locations, regulator engagement, staff hires and much more.

Ultimately a DDP describes the steps that are required to generate the evidence to support marketing authorisation and reimbursement.

An external DDP advising team needs to be expert across all regulatory affairs and product development including manufacturing, toxicology and medical writing, and planning should start from the pre-clinical development phase.

The planning process cuts risks including unexpected regulatory hurdles and cost, and ensures the drug’s progress aligns with investor expectations, as well as optimising resources throughout the clinical program.

It also covers CMC quality requirements, non-clinical requirements, the non-clinical animal studies required, and the type and scope of clinical studies to support the product registration.

In addition to the typical Phase I, II and III program, the DDP can highlight any extra requirements, or studies that might be needed to support the application, such as clinical studies in special populations, or drug interaction studies.

One of the most important processes is a commercial or competitor analysis of products on the market, or currently in development. This informs the kind of studies and information that will be needed to support the marketing authorisation of the product.

A robust DPP also identifies ways to accelerate drug approval. There are a range of processes that regulators offer in order to speed up drug development and approvals. They include orphan drug designation for a rare indications, and for truly exciting products that are impacting life-threatening disease there are options including breakthrough therapy and fast track designation programs.

DDP key points include:

Rationale

Starting off with a scientific rationale for the development of the product, which includes a brief summary of the target indication, and why the product is being developed. This sets the scene for the product development.

Competitors

An analysis of similar competitor products that are on the market or are currently in development. This is an important part of commercial analysis, but also provides useful information on the kinds of studies and information that will be needed to support the marketing authorisation of the product.

Target Markets

The product targeting could be for global registration or a single region such as the Asia-Pacific with others such as the US and Europe to be added later in the development program.

Manufacturing

An assessment of the manufacturing quality requirements at the different stages of development. Starting off with Phase I GMP, and then moving through to process validation for marketing authorisation.

Clinical Strategy

The clinical trial strategy comprising Phase I, Phase II, Phase III, may expand if say other populations need to be considered, or there may be an opportunity for a compressed clinical development strategy.

Financial

Commercial importance requires timelines and costs, or at least estimates, so a company knows how much to raise or how long it is going to take.

Decision Points

Then finally, include key decision points in the development plan where you decide whether or not it is worthwhile to continue the development of that program.