Nonclinical Development Science Services
Nonclinical Development Science Services
Strategic Preclinical Support for First-in-Human Preparation and Readiness
How well-informed is your pre-clinical drug development program?
The early drug development process can be a complex space that becomes more efficient when driven by an experienced team delivering a more robust comprehensive and integrated regulatory strategy. Certara’s Non-Clinical Drug Development Services provide support for your programs from hit to lead identification and into first-in-human (FIH)-enabling studies to include regulatory strategy and meeting support. Our experts can support the full range of early development disciplines (ADME, bioanalytical, toxicology and drug safety, and CMC) for both small and large molecules.
With a dynamic support model, Certara’s support spans from advice and gap analyses to acting as your FTE in DMPK, safety pharmacology, toxicology, clinical pharmacology and/or CMC leads on project teams. We have extensive experience ranging from CRO selection and contract negotiations to regulatory writing and submissions all the way through NDA/BLA and post-marketing commitments.
Certara’s Nonclinical Drug Development Services
How are we different?
We’re expert drug developers who know how to advise on your most critical decisions. Our success is your success – we guide and design FIH-enabling programs without conflicts of interest. We sit on the same side of the table as our clients and partner with them to develop and deploy efficient and effective best practice strategies.
We have helped to advance hundreds of programs from early clinical development stages through proof of concept and later stage clinical trials and have helped support registration (marketing) of dozens of new drugs.
Since 2017, Certara’s integrated drug development team has helped its biotech clients create up to $44 Billion in value for their organizations and investors, through IPO’s, out-licensing of drug assets and the sale of client companies to big pharma.
Get peace of mind now. Our clients benefit from complete ADME packages as well as optimized GLP toxicology/safety pharmacology programs to support an IND. We can address unexpected safety issues to prevent timeline delays and apply unique study designs to move faster into the proof-of-concept (POC) clinical studies.
Learn more about our non-clinical drug development science services.
Early drug development/Preclinical drug development support for Investigational New Drug (IND) Application
Absorption, Distribution, Metabolism, and Excretion (ADME)
Certara provides expert discovery and nonclinical DMPK drug development support. Our team designs and manages bioanalytical method development and validation, nonclinical PK and TK, in vitro and in vivo absorption, distribution, metabolism and excretion studies (including radiolabeled studies), metabolite profiling (including MIST support), enzyme phenotyping, as well as metabolic enzymes and transporter interaction studies. We will assist you in candidate selection by performing human PK parameter projections and assessing the risk of clinically relevant drug-drug interactions. Our goal is to design the optimal IND/FIH package for your drug and assure a seamless transition to the clinic by supporting FIH dose selection, clinical PK sampling scheme, and appropriate co-medication exclusion(s).
Certara’s DMPK team can also help you plan ahead with tailored nonclinical development plans and stage-appropriate gap analysis.
Certara’s Early Development Group is experienced with the requirements for ex-US FIH and drug development activities beyond FIH.
Toxicology and Drug Safety
Our toxicology services range from general input into regulatory strategy to full support of toxicology/safety study planning and execution. Our comprehensive toxicology and drug safety program support includes CRO management, protocol development, study oversight, and result reporting, culminating in the integration of key data results into regulatory documents. We support all areas of toxicology and safety pharmacology, most commonly in the IND enabling/FIH phase of development; however, this support also extends to reproductive toxicology, chronic studies, and carcinogenicity testing necessary to support late-stage clinical development and product registration. We have significant experience in impurity/excipient qualification, the design of special studies to assess mechanisms of toxicity. We also provide due diligence support for clients who are evaluating assets or preparing to have their assets evaluated. The Certara Team serves as the lead or as an extension of internal capacity, connecting the client company with a network of toxicology resources for small molecule, complex biologics, cell and gene therapies, and antibodies.
Chemistry, Manufacturing, and Controls (CMC)
Certara provides CMC support spanning from early preclinical development through Phase 3, Product Registration, and post-launch activities for both small & large molecules & diverse routes of administration. The CMC strategy covers quality standards, regulatory meeting preparation and documentation, CDMO recommendation & evaluation areas such as early phase de-risking, phase appropriate drug substance/drug product development while maintaining, and due diligence of potential opportunities to name a few. Specific areas of support:
Phase-appropriate API/drug release specifications with modifications as the program progresses towards commercialization.
- Nonclinical and FIM GMP support
- Radiolabeling activities
- Formulation support
- BE and IVIVE
- BCS classification
Meet the Experts
Expert Guidance for Efficient Studies
Nathalie Rioux, PhD
Vice President, Head of DMPK
Nathalie provides strategic DMPK & ADME discovery services, nonclinical DMPK, clinical pharmacology, and regulatory sciences for several biotechnology companies. She is also a Core Team Member of the Center of Excellence in Drug Interaction Science.
James Herman, PhD
Vice President, Toxicology
35+ years Regulatory submissions (IB/IND/NDA/MAA/CTD), Early and late nonclinical program design and execution, GI toxicology, Impurity/excipient qualification, DABT (1982-2022)
Deven Shah, BPharm, PhD
Sr. Director, Integrated Drug Development
Deven Shah is Certara’s Chemistry, Manufacturing & Controls (CMC) lead helping clients with their drug development CMC needs. Deven also supports the Certara Global Health practice area spending a significant amount of time attending to the Bill & Melinda Gates Foundation work.