Pre-Clinical – Safety, Tolerability, and Bioavailability

Our goal is to make your dream concept a commercial product, integrating our strong knowledge of ingredients and techniques to help you make the right decisions

Pre-Clinical – Safety, Tolerability, and Bioavailability

Nutraceutical market is estimated to grow phenomenally, and this growth demands the safety and efficacy of all the products that hits the market. At Pepgra’s FRL, our dedicated nutraceutical and herbal team offers wide range of clinical services to study the herbal and nutraceutical products.

Pepgra’s Food Research Lab can be the right fit for your Pre-clinical – Safety, Tolerability and Bioavailability

Our scientific research team at Pepgra’s Food Research Lab (FRL) has conducted extensive research in this area and offer an expert advice in all areas related to pre-clinical research. We offer wide range of services under pre-clinical services, and this includes

 
  • Develop research protocol that adheres to the principles of the Declaration of Helsinki and in compliance with the international Council on Harmonisation Guidelines for Good Clinical Practice (GCP).
  • We help you to register on the ClinicalTrials.gov database
  • Dosage form performance assessment: Deciding the efficacious dosage range, while providing sufficient safety margins for evaluating the effects of formulation or food.
  • Conducting bioavailability study with our partnered / networked hospitals
  • Pharmacokinetic studies: Conducting pharmacokinetic and pharmacodynamic analyses through HPLC and mass spectrometry detection (HLPC/MS) and standard non-compartmental analysis method
  • Statistical analysis and data management strictly adhering to ICH and GCP guidelines
  • Safety evaluation by monitoring for adverse events (AEs), and by performing vital sign measurements (e.g., oral temperature, respiration rate, heart rate), clinical laboratory test, physical examination.

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