Consulting Services in Regulatory and Scientific Affairs

• We have long-standing relationships with the highly regulated agencies of the USA (FDA), Europe (EMA), and Canada (Health Canada). We routinely interact with them in order to promote the safe approval and usage of drugs and to advance global regulatory science.
• We have deep knowledge of what is required clinically to prove and file for all submission types, including full (e.g., 505(b)(1)), abridged (e.g., 505(b)(2)) , and abbreviated (e.g., 505(j)) submissions for both drugs, biologic and biosimilars for US, EU, and Canada.
• We have experience with the development of innovative, generic, and biologic products.
• We offer solutions to complex drug development issues such as clinical holds, failing studies and complex or rejected regulatory submissions.
• We can support you scientifically through each phase of the drug development process, from "pre-IND" to post-marketing commitment(s).

Tailored Workshops, Courses, and Seminars

• We offer custom-made workshops, courses, and seminars that are tailored to the needs of your team and/or company, examples include:
• Transitioning from pre-clinical to First-In-Man
• PK/PD trials and analyses needed to bring an innovative, generic, or supergeneric product to market
• Noncompartmental pharmacokinetic concepts
• Compartmental pharmacokinetic concepts
• Introduction to pharmacokinetic modeling and simulations
• Population PK/PD modeling using NONMEM® and/or ADAPT5®

Study Designs, Sample Size Estimations, Protocols, and Analysis Plans

For innovative drug development, we can provide study designs, sample size estimations, protocols, and analysis plans for any kind of clinical pharmacology study, including:

• First-in-Man, SAD, MAD
• BA/BE, Food effect
• Drug-drug and drug-food interactions
• Thorough QT
• Accelerated Proof of Concept

For generic or supergeneric drug development, we can define your bioequivalence study program, including Therapeutic Equivalence studies, using a pharmacodynamic endpoint or marker if needed.

We also offer a variety of services to meet all your pharmacokinetic needs

• Modeling and simulations of one or a combination of any Phase I, II, III and IV studies.
• Analysis plan for Population PK/PD analysis using sparse or rich sampling.

Strategic Project Management and In-House Support

We provide pharmaceutical project management and other in-house support services that range in scope, such as:

• Establishing first contact with CRO(s).
• Managing the CRO selection process
• Preparing instructions for CRO(s).
• Responding to CRO questions.
• Analysis of proposals received.
• CRO selection recommendations.
• Monitoring of studies conducted by CRO(s), ensuring they respond to the defined scope, respect the approved budget and timetable, and provide high quality deliverables.
• Staffing support, where one or more of our experts acts as an employee of your company.

PK/PD Analysis and Reporting

• From simple noncompartmental to the most complex compartmental PK/PD population analyses.
• In-vitro in-vivo correlations (IVIVC).
• Prediction of minimum effective dosing regimens.
• Multi-dimensional concentration-effect modeling and predictions.
• Clinical trial simulations.
• Population PK/PD analyses using rich or sparse data.
• Complex drug-drug interaction models, with or without safety and efficacy data.
• Analysis of Therapeutic Equivalence studies using the Emax Dose-Scale approach and computations of Confidence Intervals using Bootstrap techniques

Pediatric Modeling and Simulation Reports

• Predictions of drug concentration-time profiles and dosing regimens for various age and weight categories
• Creation of Initial Pediatric Study Plan (e.g., US FDA iPSP) and/or Pediatric Investigation Plan (e.g., EMA PIP) for your drug or biological product.
• Prediction of optimal dosing regimens for your drug or biological product using modeling and simulations for various pediatric age groups (e.g., 0-2, 2-5, 6-12, 13-17 years old).
• Determination of sparse sampling collection times for your pediatric clinical pharmacology study.
• Population PK/PD analysis to confirm optimal dosing regimen to administer to various pediatric populations.

Renal and/or Hepatic Impairment Modeling and Simulation Reports

Predictions of drug concentration-time profiles and dosing regimens for various levels of renal and/or hepatic function.

Regulatory Science

• Regulatory filing in Canada and USA
• Creation or review of scientific packages for regulatory meetings (e.g., Pre-IND, pre-NDA Type B, Type C)
• Creation or review of eCTD modules
• Creation or review of product monograph (Canada), product label (USA), or SmPC (EMA)