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Very often, a client simply doesn’t have the time, staff, expertise, or capacity to complete the work they require. That’s where our services come in. From an hours’ work with one consultant, through to major, multi-national projects involving large teams, we have the right solution for you. To some clients we are their internal scientific affairs department. To others, we are a touch-point on strategic issues that arise only now and then. We are proud of a business model that is built to flex to fit our clients’ needs. Your needs will be met and your completed work will exceed your expectations. When you put a project in our hands, we treat it like our own, ensuring follow up right through the Health Authority review process.It goes without saying that we would not be in business if we could not guarantee that it is also always delivered on time on budget. We have expertise with both prescription and OTC drugs, Biologics, Natural Health Products, Medical Devices and Cosmetics.

CMC & Manufacturing

  • Regulatory compliance
  • Due Diligence, gap analysis & remediation
  • Preparation of CTD Modules 2&3
  • DMF preparation
  • Validation
  • Import documentation and licensing
  • GMP, Establishment licensing
  • Pre-approval inspections

    • Regulatory Strategy

  • Risk Management Planning
  • Response to Health Authority questions
  • Preparation and execution of Health Authority meetings
  • Scientific Advice and Protocol Assistance
  • Lifecycle management
  • Input from Subject Matter Experts
  • Pediatric development plans & exclusivity

    • Filing Expertise

  • CTAs/ITAs
  • NDS/SNDS/NC
  • DMF
  • ANDS
  • PLAs

    • Regulatory Operations & Publishing

  • CTD / eCTD / dossier preparation
  • Submission advice
  • Translation services

    • Advertising & Promotion / Labelling

  • PI / Product Monographs
  • Claim validation
  • Packaging
  • Promotional material assessment/approval
  • Opinions on PAAB and ASC viability
  • PAAB/ASC negotiations

    • Post-marketing Maintenance

  • Post-NOC changes
  • Line extensions
  • Annual Reporting
  • Pharmacovigilance
  • Safety reporting. e.g. PSURs

    • Clinical

  • Preparation of CTD Module 2&5
  • Review of protocols & CSRs
  • CTA preparation, submission, HA negotiation and clarifax responses
  • Review of IBs
  • IRB/EC documentation
  • Orphan indications
  • Amendments & Notifications
  • GCP

    • Non-Clinical

  • Preparation of CTD Module 2&4
  • Review of Toxicology & Pharmacology studies

    • Associate Training and Development

  • Technical training & development for DRA staff
  • Development of regulatory strategy
  • Health Authority negotiations & communication

    • Literature Searches & Medical writing

  • Literature Searches and reviews
  • Development of scientific documentation
  • Comparative Label reviews & surveys
  • Development of product labelling (Product Monographs, Labels, consumer Information, Package inserts)