Global Regulatory Services

QS Pharma offers the following global regulatory services.

• Scientific and regulatory advice on chemistry manufacturing & control (CMC) issues during drug development including interpretation and application of global agency (FDA, EMEA, MHW, TPP, etc.) requirements, guidelines and processes.
  


• Global strategic regulatory advice for ensuring timely approval of clinical trial and marketing applications.
  


• Preparation for global agency meetings including development of proactive strategies for negotiating and resolving CMC issues with agencies (e.g. Background/Briefing documents, Pre-IND, Pre-NDA, EOPII CMC meetings, etc.).
  


• Preparation of submissions for clinical trial applications (IND, CTX, Canadian CTA, etc.) and amendments.
  


• Preparation of global CMC marketing applications (NDA, MAA, JNDA, Canadian NDS, CTD and Abbreviated documents for other markets, supplemental applications, ANDA, etc.).
  


• Development & implementation of global strategies for T/BSE issues.
  


• Development & implementation of CMC documentation/change control systems for ensuring compliance with various global regulations.
  


• Development & pro-active implementation of CMC post approval strategies for maintaining product on the market.
  


• Preparation for FDA & international Pre-Approval Inspections (PAI).
  


• Scientific & regulatory assessment of CMC information for in-license compounds.
  


• Customized global regulatory training courses of personnel.