Pharma-orange set up our own clinical trial institution with a first class hospital and Pharmaceutical Laboratory. Our center has established the corresponding management system, design specification and standard operating procedures associated with the drug’s clinical trials. They have a wealth of clinical trials experiences. The management personnel and professional technical personnel accept the drugs’ clinical trials’ technology and knowledge of GCP training. The procedures of the drugs’ clinical trials are strictly complied with GCP.

 

Our center has a comprehensive clinical drug research infrastructure and technical conditions, and has the prerequisites to carry out the drugs’ clinical trials, in order to ensure the quality of the drugs’ clinical trials.

 

What we can do for you on the consistency evaluation:

 

Stage 1: Project Evaluation

  • The market value of the project
  • The number of competitive varieties
  • Check if there is any reference preparation(RLDs)
  • Assess the costs and cycles required
  • Consult relevant officials and experts
  • Project approval and carry out

Stage 2: Pharmaceutical Research

  • The selection and filing of reference preparation (RLDs)
  • Purchase Reference Listed Drugs
  • Compared with the quality of the RLDs (mainly containing dissolution curves and impurities)
  • Drug equivalence determination
  • Secondary development of prescription technology
  • A comparison of soluble curves
  • Prescription process to determine and pilot enlarge
  • Three batches of pilot product process verification
  • The quality of the pilot sample is consistent with that of the reference preparation(RLDs)
  • API solubility and permeability studies (limited BCSI and BCSIII class)
  • Formulation stability and package inspection
  • Declare the compilation and compilation of information, provide the original records

Stage 3: BE research

  • BE research program development
  • Statistical analysis of the plan
  • Phase I clinical base, biological sample testing units and so on
  • Ethics Committee review
  • Record on the CDE’s BE filing
  • Validation of biological sample analysis methods
  • Subjects were recruited
  • Subjects take drugs and biological samples collected
  • Analysis of biological samples
  • Data management and statistical analysis
  • Write a summary report

Stage 4: Project Declaration

  • Prepare all the documents that needed from CFDA and Hand over to CENTER FOR DRUG EVALUATION(CBE)
  • Site inspection and production site inspection of CBE
  • All Data is summarized in the CBE Office
  • Obtained Consistency Evaluation