Explore Our Services

Explore Our Services

Nuventra’s drug development consultants work as an extension of your team. We provide strategic consulting services to maximize the impact of each study on your overall development program. Match your pipeline to our services below and let us know how we can help.

Nonclinical to IND

Nuventra’s nonclinical goal is to efficiently move our clients' compound into the clinic. We apply the smartest tools and strategies for attaining a successful IND and entering the clinic with a strong rationale for the first-time-in-human dose.

PK/PD/TK

  • Noncompartmental Analysis
  • GLP and Non-GLP
  • Submission Ready Study Reports

Regulatory, Writing & Strategy

  • Nonclinical and Clinical Development Plans
  • Advice and Design of IND-enabling Studies
  • IND Authoring (full or sections), Review, Publishing & Submission (CTD / eCTD)
  • Regulatory Agency RFIs, Meetings, Planning & Representation
  • Guidance Document Interpretation

PopPK, Modeling & Simulation

  • Model Based Drug Development
  • Candidate Selection
  • Allometric Scaling
  • Predict Human Exposure
  • Exposure Response
  • Dose Selection, Justification
  • Study Design Simulations

Vendor Identification & Management

  • Bio-analytical
  • Pharmaceutical development
  • Toxicology

Early Phase

There is much more to early phase development than simply checking off required studies. We work with clients to create plans that ensure each early phase study fits into your overall drug development program. Before starting any clinical study, we ask: How do these studies fit into the overall drug development strategy? How can clinical pharmacology data support late phase, efficacy and pivotal study success? What other data will be required to support the submission?

PK/PD/TK

  • Noncompartmental Analysis
  • GLP and Non-GLP
  • Submission Ready Study Reports

PopPK, Modeling & Simulation

  • Population PK Analysis
  • Exposure Response
  • Dose Selection, Justification
  • Study Design Simulations

Regulatory, Writing & Strategy

  • Gap Analysis/QBR
  • Clinical Pharmacology Plan
  • Study Protocol
  • Regulatory Agency RFIs, Meetings, Meeting Requests, Planning, Briefing Packet Preparation, Representation

Clinical Operations

  • Study Design and Conduct
  • Site Qualification
  • Data Fidelity/CDISC
  • Vendor ID/Management
  • Biostatistics

Late Phase

Nuventra utilizes innovative modeling and simulation techniques to ensure that your program is ready for the approval process. Our Pharmacometricians ensure justification of dose for the marketplace, and author reports to detail their findings. We can use modeling and simulation to avoid certain late phase studies, scale to pediatrics, simulate entire studies, and more.

PK/PD/TK

  • Noncompartmental Analysis
  • GLP and Non-GLP
  • Submission Ready Study Reports

PopPK, Modeling & Simulation

  • Population PK Analysis
  • Identify/Confirm Predictive Covariates
  • Dose Selection, Justification
  • Comparator Analysis
  • Study Simulations
  • Exposure Response
  • Concentration QT
  • Model Risk
  • Large-scale NONMEM

Regulatory, Writing & Strategy

  • Gap Analysis/QBR
  • TQT Waiver
  • PIP/PSP (required for Ped Populations)
  • Regulatory Agency RFIs, Meetings, Meeting Requests, Planning, Briefing Packet Preparation, Representation

NDA/BLA

Nuventra has considerable experience with regulatory agencies around the globe. We work with our clients and the regulatory agencies to ensure that all documents are robust, insightful, scientifically focused and practical. You have invested significant resources to reach this point, contact the experts at Nuventra to ensure your submissions and/or strategic responses are well received by the agencies.

Regulatory, Writing & Strategy

  • Perform Gap Analysis/QBR
  • Guidance Document Interpretation
  • NDA/BLA (Full or Sections)
  • NDA/BLA Publishing and Submission (CTD/eCTD)
  • Regulatory Agency RFIs, Meetings, Meeting Requests, Planning, Briefing Packet Preparation, Representation