BIOAVAILABILITY / BIOEQUIVALENCE STUDIES :

Our clinical researchers, Pharmacokinetist, pharmacologists, statistician and software specialists design the scientific studies and they are responsible for collection and analysis of data in order to evaluate the plasma concentration of the drugs required for regulatory authorities.

SALIENT FEATURES OF CLINICAL FACILITY :

• A clinic with 40 beds facility and an ICU.

• Separate Screening, Drug storage, entertainment, dinning and phlebotomy area.

• A team of GCP-trained professionals .

• Standard Operating Procedures to comply with GCP.

• Independent Ethics Committee.

• Extensive database of subjects.

• Accreditated /certified laboratories.

WHAT WE DO :

• Protocol Development

• CRF Designing

• Statistical Analyses & Interpretations.

• Study report generation as per the regulatory requirement.

• Design and conduct of :
  i. Single Dose / Multiple Dose Studies
  ii. Single Dose Multiple Periods Crossover Studies
  iii. Fasting and/ Fed studies
  iv. In-House and/Ambulatory studies
  v. Dose Proportionality Studies
  vi. Cross over and/Parallel studies.

ACCREDITATIONS :
1. ANVISA, Brazil.
2. MCC South Africa and WHO, Geneva.

SALIENT FEATURES OF BIO-ANALYTICAL FACILITY :

• Well equipped with automated HPLCs

• Full range of detectors (UV, Fluorescence, ECD and RI)

• Well qualified and trained scientists

• LC-MS and LC-MS/MS

• Solid Phase extraction system

• Refrigerated centrifuge

• -20ºC Deep freezer facility.

WHAT WE DO :

• Sample processing
• Method feasibility: Enabling the identification of most appropriate method for the detection of the drug in biological samples
• Method development : Utilizing scientific expertise to develop methods specific for drugs.
• Method validation: In accordance with the regulatory guidelines, validation criteria are compliant, ensuring a robust and reliable assay that delivers sensitivity and selectivity.
• Revalidation of the assay method
• Biological sample analysis of drugs and / or metabolites for pre-clinical and clinical studies.

FORMULATION DEVELOPMENT:

Pharmaceutical development is one of the most challenging areas, which involves integrating numerous regulatory requirements with the complexities of pharmaceutical science and manufacturing. We provide a full range of custom-designed development services in following areas:

• Expertise in the oral and the parenteral formulations
• Novel Drug Delivery System
• Formulation development and dossier preparation as per CTD.