PK/PD studies

 

Our focus is to provide all-sized pharma companies with expertise

on PK/PD services for their clinical studies. 

Our team offer a strong expertise in variety of therapeutics areas and 

all necessary regulatory process and requirements. 

Our experts provide clinical and regulatory inputs for the following

types of pharmacology studies in yearly and late phases: 

 

  • Single Ascending Dose /Multiple Ascending Doses
  • Bioequivalence and bioavailability studies
  • Food effect studies
  • Drug-drug interaction studies
  • Phase IIa / Proof of concept
  • Thorough QT/QTc

 

We start our projects with in 60 days of the initial regulatory

submission. We provide adequate solutions in order to complete

our Sponsor companies' projects on time and on budget.

We rely on in-house SOPs developed in compliance with

ICH-GCP Guidelines.

 

Our pharmacological research unit includes but is not limited to:

 

  • Twelve beds with IV infusion capability

  • Sample processing room

  • Emergency room

  • Refrigerated and ambient centrifuges

  • Access-controlled sample storage area

  • Freezers supporting 4°C, -20°C and -80°C 

  • Temperature monitoring and alarm systems

  • ECGs, electronic blood pressure monitors, holter monitors

  • Emergency resuscitation equipment

  • Emergency devices in all areas

  • Audio communication system

  • Synchronized clock system

  • Comfortable lounge area

  • Dining area and catered meals

  • PCs, WiFi, PC games, board games, HD TVs, DVD library

  • 24/7 monitoring and video surveillance system
  • Fire alarm system
  • Standby generator
  • SOPs