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Regulatory Affairs & Pharmacovigilance
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Regulatory Affairs

VST has the contacts and the knowledge to maximize your chances of success with regulatory authorities around the world. Our international team offers expert strategic advice and produces high-quality submissions, giving you access to the widest possible market in the shortest possible time.

Our experience encompasses international clinical trial approvals, registrations of new chemical and biological entities, and the development of new medicinal products. We devise and implement high-level regulatory strategies, expedite the registration of new drugs and biologics, manage all aspects of generic submissions as well as post-approval activities. For smaller organizations, we often serve as a virtual regulatory department, providing expertise as required while avoiding the expense of full time staff.

Pharmacovigilance

VST helps clients proactively meet regulatory and drug safety requirements throughout their product’s lifecycle. Our holistic, risk-based approach addresses every stage of clinical trial activities, from initial protocol design to study reporting.

Working on a national and global scale, our experts can devise an entire system or enhance your existing program with specialized expertise. Whatever your stage of development, SRA can help you make the right commercialization choices for your product.

Benefits

  • Deep domain expertise provides the insight you need when you need it
  • Extensive experience with major regulatory bodies prevents costly mistakes
  • Strategic advisory experience, qualified staff, and quality processes ensure our work is done correctly the first time
  • Global reach and deep domain expertise reduce time and cost
  • Efficient system implementation
  • Streamlined regulatory process and safety reviews
  • Enhanced data quality and compliance

Services

  • Regulatory Submissions
  • Advisory Services
  • Agency Interactions
  • Paediatric Investigational Plans (PIPs)
  • In-house placements (should you prefer to have our regulatory experts on site)
  • SME status support
  • Development of product labelling
  • Target Product Profiles
  • Strategy and planning
  • System design, development and implementation
  • Compliance review of existing systems and processes
  • Data management
  • Regulatory reporting
  • Training in EU or US regulations and guidel
  • Post marketing support
  • Electronic reporting of Serious Unexpected Suspected Adverse Reactions (SUSARs) to regulatory bodies
  • Preparation and submission of Investigational New Drug (IND) safety reports
  • Preparation and submission of quarterly and annual safety reports
  • Manage all aspects of Serious Adverse Event (SAE)