Our team and scientists haave a broad experience in drug development in various therapeutic areas to provide a thorough assessment of programs for investors and capital venture companies or provide these services to perform due diligence on candidate assets. In addition we can prepare clients that are subject to a due diligence by potential investors to participate and put forward the best and most balance features of their program. Inncelerex provide:

  • Assessment of strengths and weaknesses of the asset
  • Gap analysis
  • Identification of required investigations or studies
  • Assess the probability of technical and regulatory success
  • Potential differentiation strategies 
  • Competitor comparison in relation to predicted efficacy or safety differentiation of the asset 

  

Modeling & Simulation

Regulatory Interactions and Submissions 

Our team and scientists have extensive experience in regulatory interactions:

  • Experience with FDA, EMA, MHRA and PMDA
  • Pre-IND meetings
  • IND preparation and submission
  • End of Phase I Meetings
  • End of Phase II Meetings
  • ​Advisory Board Meetings
  • Type A, B and C Meetings
  • NDA submissions
  • ​Post Marketing Commitment/Requirement Discussions

We provide a full spectrum of services described above from pre-IND through NDA. Majority of small or medium size pharmaceutical companies would not need or can afford a full department for Early Development, Clinical Pharmacology and Modeling & Simulation. We at Inncelerex fulfill this need and work as an integrated full service function:

  • Guide and navigate clients through Clinical Pharmacology and Early Development
  • Integrated PK and PK-solutions
  • Build differentiation strategy at early stages of development  

Early Development Function for Start UP and Medium Size Pharma Companies

We provide a wide variety of expertise in Modeling & Simulation including:

  • Development of Population PK model building in animal
  • Development of Population PK model building in humans
  • Allometric scaling and interspecies population PK model
  • PK-efficacy relationship
  • PK-side effects and safety relationship
  • Identify covariates and predictors of exposure (e.g., demographics)
  • Risk-benefit analysis for optimized dose selection/justification
  • Exposure-QT relationship using Phase I/II data to obtain regulatory waiver
  • End of Phase I or Phase II Population PK and PK-PD to guide dose selection and for design of optimal dose ranging studies
  • PK-efficacy and PK-adverse event relationship to justify dosing regimen for NDAs
  • Pediatric population PK  modeling  to determine the optimal dose for first pediatric studies and for NDA submissions
  • Benchmarking and competitor analysis

Translational Medicine Studies

Clinical Pharmacology and Human Pharmacokinetics


Toxicokinetics and Animal PK-PD Studies


Design, analysis and reporting of studies in different animal species to characterize PK in pre-clinical species and determine the relationship between exposure and toxicity end points (NOEL and NOAEL) or determine the exposure-efficacy or biomarkers. The expertise we provide include:

  • Optimized PK sampling scheme
  • Extrapolation of animal PK to humans (allometric scaling)
  • Prediction of safety margins in humans for First-in-Man study 
  • Analysis of relationship between exposure and toxicological findings
  • Analysis of relationship between exposure and efficacy or biomarkers

Due Diligence

We provide a full range of integrated services for Clinical Pharmacology study design, oversight, analysis and reporting. The example of studies we provide services for are as follows:

  • First-in-Man Studies
  • Single Ascending Dose
  • Multiple Ascending Dose
  • Drug-Drug Interaction
  • Renal Impairment
  • Hepatic Impairment
  • Thorough QT
  • Age and Gender
  • Food Effect
  • Bioequivalence/ Bioavailability
  • Mass Balance/ Radiolabled
  • Route of Administration
  • Pediatric

In addition to providing services for the specific studies, we design and implement the Clinical Pharmacology strategy for development programs and define the priority of studies and their impact, in order to recommend the most balanced risk-benefit for a development program and to ensure an informed decision tailored to each individual program.

We provide a wide variety of expertise in Modeling & Simulation including:

  • Development of Population PK model building in animal
  • Development of Population PK model building in humans
  • Allometric scaling and interspecies population PK model
  • PK-efficacy relationship
  • PK-side effects and safety relationship
  • Identify covariates and predictors of exposure (e.g., demographics)
  • Risk-benefit analysis for optimized dose selection/justification
  • Exposure-QT relationship using Phase I/II data to obtain regulatory waiver
  • End of Phase I or Phase II Population PK and PK-PD to guide dose selection and for design of optimal dose ranging studies
  • PK-efficacy and PK-adverse event relationship to justify dosing regimen for NDAs
  • Pediatric population PK  modeling  to determine the optimal dose for first pediatric studies and for NDA submissions
  • Benchmarking and competitor analysis