Experts in Conducting FDA and EMA Meetings and Filings; Integrated Regulatory, Scientific, and Clinical Strategies
WE ARE GLOBAL REGULATORY & CLINICAL EXPERTS
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.
What Makes Us Different?
We are not simply consultants; we are an extension of the client team in global development and strategy.
We are not just regulatory experts; we are scientists and clinicians who understand regulatory agencies and what is required for product development and approval.
Everything we do is customized to client needs with regard to development stage, financial planning, and corporate goals.
We strive for excellence and to create value. We are committed to your success!
News & Updates
What Can We Do For You?
Global Product Development, Clinical Strategy, and Regulatory Submissions since 2001
Novotech Drug Development Consulting provides comprehensive product development services to 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. Our scientific, clinical, and program development expertise has resulted in numerous biotech, drug, and device approvals through FDA and other global regulatory authorities.
We also offer comprehensive electronic submissions services, with over 15 years of experience.
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 firstname.lastname@example.org.
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We have opportunities for professionals at all levels!
Please visit our Careers page to learn more about working at our company and about current job opportunities.
We would like to hear from you!
Phone: +1 720 746 1190
Fax: +1 720 746 1192