Service

Pharmeteo has years of successful regulatory submission experiences. We want your product to move through the regulatory process, gaining approvals and ultimately helping patients.

US Agent Representation – We can be your formal regulatory agent to the FDA, responsible for submissions and formal communications directly with FDA through the FDA Project Manager. This coupled with our submission processes provides a seamless interaction to agencies with prompt information relay to Client.

Gap Analysis – Review your past regulatory interactions, current CMC Information, Nonclinical and Clinical Studies, and assess for additional documentation or needed studies for your therapeutic area submission for a successful application approval.

Meet with Health Authorities – Our experienced expert begin their involvement with the Gap Analysis and work with you to build your submission strategy, agency communications, and accompany you to meet with regulatory agencies.

• Regulatory strategy and integrated drug development across all phases, therapeutic areas, and patient populations (including pediatrics)

• Dose justification, candidate selection, first-in-human, proof of concept, dose-ranging safety and efficacy studies, registration, and lifecycle management

• Full-service Pre-IND, IND, NDA, and ANDA support

• Interpretation of pre-clinical data as a guide for next steps in clinical pharmacology programs

• Drug-drug interaction (DDI) waiver justifications. In vitro/in vivo transporter and DDI study guidance

• Interpretation of industry guidance documents for individual clinical pharmacology development programs

Pharmeteo has deep experience in delivering the study rationale, design, dose justification, participant population rationale, PK and/or PD sampling strategy, analysis plans, interpretation, and reporting of data for clinical trials across all phases.

Clinical Study Strategy and Design Services:

• Clinical pharmacology development strategy

• Study design and protocol development

• Dose rationale and dose administration

• PK and PD sampling schedule

• Inclusion/exclusion criteria

• Robust PK and PD analysis

• Clinical study report (CSR) and/or standalone PK report

• Contribution to Pre-IND, Briefing document, IND/NDA modules’ writing

• IB, Label and Safety update

Clinical Pharmacology Studies Supported:

• First-In-Human (FIH), Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)

• Proof of Concept and Larger Dose Ranging

• Thorough QT/QTc (TQT), including cQT analysis

• Relative Bioavailability and Pivotal Bioequivalence

• Drug-Drug Interaction (DDI)

• Food Effect

• Large Registrational Safety and Efficacy, to establish population PK and exposure-response (PK/PD)

• Renal Impairment and Hepatic Impairment

• Pediatric and Elderly

• Site of Absorption

• Radio-Labeled Mass Balance

With Model-Informed Drug Development (MIDD) can help inform decisions that increase the probability of success in clinical studies and reduce the cost of drug development overall. The FDA and EMA have both acknowledged that MIDD is an essential component across all drug development programs involving new molecular entities.

Population Pharmacokinetics (PopPK)

Population pharmacokinetics is used to understand the variability in drug concentrations among individuals in a group of interest . Patient characteristics. Understanding this variability can help establish a robust PK/PD profile and inform safe and effective dosing regimens.

• Model-Informed Drug Development Plan

• Statistical Analysis Plan (SAP) or PK Analysis Plan (PAP) development

• Population PK/PD, Exposure-Response Analysis, dose Selection and Justification

• Concentration QT (cQT) Modeling

Physiologically Based Pharmacokinetics (PBPK)

PBPK modeling is a tool that uses physiologically relevant mathematical descriptions of biological processes to make quantitative PK predictions.

• Physiologically Based Pharmacokinetics (PBPK)

• Drug-drug Intercation (DDI)

• Bioavailability (BA) and bioequivalence (BE)

• First in Human (FIH)

• Food Effect

• Renal Impairment and Hepatic Impairment

• Pediatric and Elderly

Non-compartmental analysis (NCA)