The Biologics Practice, under the direction of Ellen Feigal, MD, provides expert guidance and support for the development of large molecules, from initial concept to BLA/MAA/351(k) submission. Biologics comprise a very heterogeneous and broad spectrum of medical products, including products made from viruses, bacteria and other organisms, therapeutic serum, toxins, antitoxins, vaccines, blood, blood components or derivatives, allergenic products or analogous products, cell and gene therapies, protein drugs, monoclonal antibodies, and synthetic peptides of 100 amino acids or more in length. Each type of product requires a unique regulatory approach based upon scientific challenges for specific biologic diagnostics and therapeutics.
The Medical Device Practice, under the direction of David Feigal, MD, MPH, offers a wide range of services to assist in the development of novel devices, including medical equipment, implants, in vitro diagnostics, imaging, and companion diagnostics, mobile and analytical software devices, combination products, and drug delivery devices. NDA Partners Expert Consultants help devise effective development strategies, determine optimal regulatory pathways, plan and manage key projects, prepare and submit US and EU regulatory filings, manage regulatory affairs in the US and internationally, design and implement quality management and risk management systems, provide guidance on CLIA regulations, conduct GMP and GCP audits to ensure regulatory compliance, and address critical issues that arise during development programs.
The Drug Development Practice, under the direction of Carl Peck, MD, provides a comprehensive range of services to assist clients in the development and registration of new drugs in the US and EU. NDA Partners Expert Consultants can assist in addressing technical, scientific, and medical issues and in designing and implementing product development and regulatory strategies. Services include regulatory pathway and landscape assessments, readiness reviews for regulatory submissions, clinical study design, planning and preparations for regulatory agency meetings, pediatric program planning and clinical study design, regulatory submissions, and applications for special designations.
The Generics Practice, under the direction of Phil Goliber, PhD, provides services that facilitate development and registration of generic products, including determination of optimal regulatory pathways, development strategy, CMC development plans, assessment of product readiness for regulatory submission, design and implementation of quality management systems, management of regulatory submissions, communications with regulatory agencies, and assistance in technical areas such as formulation design and assessment, bioequivalence, analytical methods, and manufacturing design (including Quality by Design and design space). NDA Partners Expert Consultants have extensive experience in developing generic, biosimilar, and interchangeable drugs in the US and EU, including ANDA 505(j)(2), 351(k), and 505(b)(2) regulatory pathways.
The Product Quality & CMC Practice, under the direction of David Savello, PhD, is focused on requirements for chemically synthesized molecules intended for submission in 505(b)(1) and 505(b)(2) applications to the FDA and comparable submissions in the EU. It incorporates expertise in biopharmaceutics (bioavailability and bioequivalence), microbiology, and compliance. The focus is on phase-appropriate CMC development strategies and planning, including requirements and materials for nonclinical and clinical testing; evaluation of drug substance (API), dosage form, route of administration, and delivery technologies; manufacturing scale-up; regulatory agency communications; regulatory submissions; and product development, including Quality by Design. In addition, Expert Consultants assist clients in responding to and remediating regulatory agency inspection issues, infractions, and warning letters regarding product quality and CMC.
The Quantitative Drug Development Strategies (QDDS) Practice, under the direction of Roger Williams, MD, helps clients design, analyze, and execute successful product development programs that address their most difficult issues using efficient study designs and regulatory strategies that have a high likelihood of success and that can accelerate timelines. Utilizing state-of-the art quantitative methodologies and data-driven approaches, including quantitative clinical pharmacology, PKPD/PBPK and systems pharmacology analysis, modeling, and simulation, clinical simulation, and adaptive trial designs, and FDA-encouraged Model-Informed-Drug Development (MIDD) and Complex Innovative Trial Designs (CID) procedures for dosage optimization, the QDDS Practice helps clients predict optimal dose and clinical outcomes more accurately, optimize information value and efficiency of clinical trial designs, identify patients who would benefit most from therapy, and produce compelling evidence of effectiveness. By focusing on the most clinically relevant development questions, NDA Partners supports the design and execution of clinical trials that can accelerate development programs and produce high-quality regulatory packages containing the data needed to secure regulatory approval without delays.