Biopharmaceuticals Consulting Group

Regulatory and Compliance
We provide you services for:

  • Regulatory submissions for product       
    licensing In U.S. And International
  • IND, BLA, NDA, MAA, CTD
  • Comparability protocols and Reports
  • Stability reports
  • Clinical reports
  • Drug Safety reports
  • Submission of Post-approval changes
  • Preparation for Pre- and Post-approval
    Inspection
  • Auditing and Supplier management
    systems
  • Licensing Facilities
  • Annual Reports
  • Science based interpretation of rules
    and regulations
  • Product Complaints
  • Pharmacovigilance

GMP and GLP Compliance for Clinical and Commercial Products
We provide:

  • Basic GMP Training
  • Specific GMP training
  • Training for System-based inspection
  • GLP Training
  • GXP training

Required Quality Systems for each product stage
  • Change Control
  • Validation, Qualification
  • Technology Transfer
  • Documentation
  • Training
  • Material tracking
  • Release
  • Laboratory systems
  • Outsourcing

Customized in-house training according to your needs

QA Systems
    Will assist you to implement systems for:
    ·        Documentation
    ·        Auditing
    ·        Inspections
    ·        Annual Product Review
    ·        Training
    ·        Deviations
    ·        Supplier Management and Vendor Qualification
    ·        Product Release
    ·        Investigations
    ·        Change Control
    ·        Material tracking and disposition

QC Systems
Will establish all laboratory systems for you:
    ·        Training
    ·        Documentation
    ·        Method development and validation
    ·        System Validation
    ·        Instrument Validation and qualification
    ·        Stability
    ·        Standards
    ·        Microbiological validation
    ·        Environmental Monitoring
    ·        Alert/action notification
    ·        Establishing Meaningful Specifications
    ·        Technical Evaluation
Process Development and Manufacturing

We provide consulting services for all your needs
in :

·        Product Characterization
·        Process validation
·        Process monitoring
·        Process Analytical Technology
·        Technology transfer
·        Change Control
·        Technical evaluation
·        Material tracking
·        Facility validation
·        Investigation
Biopharmaceuticals
Consulting Group