Kwan Regulatory Consulting - Strategic Regulatory Solutions Services

By: Kwan Regulatory Consulting  09-12-2011
Keywords: Mentoring, Regulatory Consulting

Leadership and Mentoring

Kwan Regulatory Consulting has extensive experience in the pharmaceuticals industry, with demonstrated skills and strengths leading the development and the implementation of corporate strategy. KRC has a proven ability in building, mentoring and leading high performing cross-functional teams, resulting in efficient delivery of strategic and operational objectives.

  • Help companies navigate the intricate regulatory process at Health Canada
  • Bridge temporary resource needs during start-up or leaves of absence
  • Mentor and train regulatory staff at all levels
  • Assist companies in early start-up to ensure compliance
  • Act as primary in-country contact for Health Canada

Strategy Activities

Regulatory Strategy
Implementing a global regulatory strategy is critical to efficient drug development and the successful approval of products. Kwan Regulatory Consulting has significant experience incorporating Canadian submission requirements into the global plan.

  • Develop regulatory strategies for Canadian submissions
  • Assess and provide input to enhance established Canadian submission plans
  • Validate and/or enhance current global strategies to meet TPD requirements
  • Conduct due diligence for potential in-license opportunities

Product Life Cycle
Regulatory input during the entire product lifecycle has a huge impact on market success. Kwan Regulatory Consulting has significant experience in providing regulatory advice to turn the regulatory component into an enabler in life-cycle strategies:

  • Maximize product exclusivity afforded by the Patent Medicines Regulations (a.k.a. Patented Medicine Prices Review Board (PMPRB) regulation).

Submission Management

Kwan Regulatory Consulting has the expertise to manage all types of regulatory submissions throughout the product life-cycle, including:

  • Submit to Therapeutic Product Directorate (TPD)
    • Clinical Trial Applications (CTA)
    • Supplemental New Drug Submissions (SNDS)
    • New Drug Submissions (NDS)
  • Prepare, file, and follow up on submissions to TPD
  • Develop submission strategies to maximize chance of success
  • Facilitate the submission review process with Health Canada
  • Act as in-house Regulatory expert for start-ups or contract research organizations.

Keywords: Mentoring, Regulatory Consulting

Contact Kwan Regulatory Consulting

Email - none provided

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