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Certification services
 
Regulatory Support Services
 
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Biotech Industrial Training Programme                      
 
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Regulatory Support Services

 
BCIL offers the following regulatory support services to the Industry, Research Institutes and Universities
   
  1. Preclinical and Clinical Development Services

  2. GLP Certification of the Animal House Facilities
   

Scope of Services

1. Pre-clinical and Clinical Trials
  1. Review of existing data
  2. Protocol writing (study document development)
  3. Approval of protocols for clinical trials
  4. Selection of investigators
  5. Site identification and screening
  6. Ethics committee submission
  7. Study initiation
  8. Medical writing
  9. Data management and analysis
  10. Project management and vendor management
  11. Dossier preparation
 
2.GLP Certification of the Animal House Facilities
  1. Assessment of existing animal house facility and performing a GAP analysis
  2. Providing effective solutions for addressing the gaps identified, if any
  3. Documentation work required for GLP certification
  4. Pre-assessment audit to ensure that the facility meets the desired certification requirements
  5. Assistance during final certification audit to facilitate the GLP certification
  6. Training of the Staff
  7. Assist in writing Standard Operating Procedures (SOPs) for conducting preclinical studies, maintain GLP compliance etc.
  8. Assist in obtaining GLP certification of preclinical regulatory studies conducted by the client
 

For providing high quality and cost effective regulatory support services, BCIL has empanelled Clinical Research Organizations (CROs). BCIL adopts a highly systematic process for providing value to the client consisting

  1. Developing an appropriate strategy for taking forward the promising drug candidates/products through the National/International regulatory pathway based on assessment of market potential to realize its maximum potential.
  2. Identify the most suitable CRO having adequate domain expertise. i.e. product category wise/activity wise/stage wise/ territory wise (National/ International) experience for the preclinical/clinical trial.
  3. Developing a timeline based implementation plan and ensuring strict compliance with the timelines to ensure expediency of movement from one stage of Clinical Development to the next without loss of time and consequently prevent erosion of Patent Life.
 
   
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