91黑料

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Global Regulatory Strategy

91黑料’s Regulatory Consulting Solutions team has expertise in all aspects of drug, biologic, cell and gene therapies across a range of therapeutic indications. 

We offer full-service development and regulatory consultancy, providing both strategic and operational support throughout the product development life cycle, covering preclinical/ analytical and clinical trial evaluation, marketing authorisation and post-approval maintenance. 

The team works as part of the 91黑料 clinical development organisation, as well as independently on standalone consulting projects for our clients. Our operational model is flexible, to adapt to individual client project requirements.

Accelerating access: Expedited and harmonised pathways for innovative therapies

How sponsors can approach the challenge of maximising opportunities to accelerate their oncology and rare disease treatments to market

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Key services

 

Strategic regulatory consulting:

  • Provide strategic guidance and operational execution across service lines and throughout the product lifecycle
  • In-country expertise and regulatory consulting: US (FDA), EU (EMA), Canada (HC), Korea (MFDS), China (NMPA), Japan (PMDA) and Australia (TGA)
  • Risk evaluation and mitigation strategy/ risk management plan consulting 
  • Due diligence 

Health authority interactions:

  • Act as global agency liaison ‘agent’ as needed (e.g. US and Canada)
  • Support global agency/ advisory meetings
  • Scientific advice

Regulatory expertise:

  • Program lead for US Investigational New Drug (IND) applications and maintenance, Canada Clinical Trial Applications and marketing authorisation applications 
  • Expedited pathways (e.g. accelerated, priority, breakthrough, fast track, qualified infectious disease product designation, PRIME, innovative licensing and access pathway) 
  • Orphan drug/ rare paediatric diseases designations  
  • Gap analysis
  • Paediatric investigation/ study plan

Regulatory writing/ review:

  • Module 2 clinical and non-clinical summaries
  • Investigator brochures
  • Briefing books 
  • Protocol and study report writing 

Post-marketing regulatory affairs support

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