EXPERTS IN DRUG DEVELOPMENT, CLINICAL PHARMACOLOGY AND PHARMACOMETRICS

Consulting services in Regulatory and scientific affairs

Tailor-Made Workshops, Courses and Seminars

Definition of Study Designs, Sample Size, Protocols and Analysis Plan

For the development of any innovative drug, we will define your study design, quantify its sample size, define your protocol and finally, define endpoints and criteria to meet or pass

For the development of any generic or supergeneric drug, we will define your bioequivalence study program, including Therapeutic Equivalence studies, using a Pharmacodynamic endpoint or marker

We also offer a large scale of services adapted to all your pharmacokinetics needs

Strategic project management

L&C may also assist you in the execution of clinical studies or in any other type of studies related to the development of innovative, generic or supergeneric drugs:

PK/PD analysis and Reporting

Pediatric Modeling and Simulations Reports

Predictions of drugs concentration time-profiles and dosing regimen for various age and weight categories, including their efficiency and toxicity

Renal Impairment Modeling and Simulations Reports

Predictions of drugs concentration time-profiles and dosing regimen for various levels of renal function, including their efficiency and toxicity

Other reports and Expert opinion