Document required for registration of bio availability and bioequivalence centre

  1. Name and address of the organization to be registered along with its telephone no., fax no. and email address.
  2. Document regarding legal identity of the centre.
  3. Name and address of the proprietors or partners or directors.
  4. An organogram of the centre including brief Curriculum Vitae of Key personnel
  5. Documents to ensure Impartiality, confidentiality, independence and integrity of the centre.
  6. List of equipment in the firm.
  7. List of staff in firm
  8. List of Standard Operating Procedures for various activities
  9. Layout of facility
  10. Details of Ethics Committee including its registration number
  11. Facilities for maintenance of records.
  12. Details of Retention of samples
  13. All major tie ups for ancillary services like ambulance, hospital etc.
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