Drug Consulting Services

Drug Consulting Services in Canada and United States

Drugs range from simple topical creams to complex prescription drugs.  This category also includes many products that are considered cosmetics in some markets, such as some SPF or Acne Products.  With Focal Point Research’s expertise in  Drug regulations, we can help assist bringing your product to market successfully.

Focal Point Research offers the following
Drug Consulting Services:

OTC DRUGS – Pharmacovigilance (CANADA AND USA)

  • Establish and implement procedures to receive, analyze, submit and maintain Adverse Drug Reaction (ADR) records
  • ADR evaluation for seriousness and reportability
  • Facilitate filing of ADR reports to, and communication with, the Canada Vigilance Program and the FDA
  • Prepare annual summary reports and issue-related summary reports
  • Conduct literature scans, signal detection, identification of trends
  • Preparation for Health Canada Good Pharmacovigilance Practices (GVP) Inspections
  • Host or provide support for Health Canada GVP Inspections and subsequently implement corrective actions

Regulatory Affairs:

  • Complete U.S. FDA electronic submissions for drug establishment registration and drug listings in SPL format
  • Prepare and submit applications to Health Canada for product approval (Drug Identification Number – DIN)
  • Manage post-approval changes such as product reformulation or new labelling/claim modification
  • Prepare applications for the approval of manufacturing, packaging/labeling, importing, distributing, wholesaling, and testing facilities(Drug Establishment License Approvals)
  • Assist with product importation to Canada
  • Prepare and submit New Drug application (NDA), Abbreviated New Drug Application (ANDA) and Investigational New Drub (IND) Applications to the FDA
  • Prepare and submit New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS) and Clinical Trial Applications (CTA) to Health Canada
  • Preparation of Drug Submissions in eCTD Format

Quality Assurance:

  • Conduct Drug GMP audits
  • Host FDA & Health Canada GMP Inspections
  • Prepare and review Standard Operating Procedures (SOPs)
  • Manage pharmacovigilance activities including consumer complaints and Adverse Drug Reaction (ADR) investigating and reporting
  • Act as QA to release products for sale in Canada
  • Manage complete testing of drugs
  • Prepare product technical files

CONTACT

The Focal Point Research team of consultants is ready to help with your scientific & regulatory needs. Our friendly staff include scientists from various disciplines, regulatory and packaging experts and administrative support. We are eager to help you.

We provide our expertise to various businesses located throughout Canada and the United States, such as Toronto, Montreal, New York, Los Angeles, and many more.

GIVE US A CALL

  • 181 Lakeshore Road E. Mississauga, ON
  • mail@focalpointresearch.net
  • 1 (905) 271 2709
  • www.focalpointresearch.net

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