Topical OTC Drugs

Topical OTC Drug Consulting Services in Canada & United States

OTC Drugs can range from simple topical creams to more complex products.  This category also includes many products that are considered cosmetics in some markets, such as some SPF or Acne Products. Whether you are creating a new product, or enhancing an existing one, we have the know-how to get your product to market.

 

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Focal Point Research offers the following
 Topical OTC Drug Consulting Services

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)
  • 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
  • Assist with product importation to Canada
  • 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
OTC DRUGS (Topical) – 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

“Focal Point Research has consistently and professionally looked after regulatory and quality issues of our brand for years. Through a courteous and knowledgeable team, they have managed to navigate us through an ever changing regulatory landscape while maintaining our interests, and allowed us to correctly distribute and sell within Canada.”

“I have truly enjoyed working with you over the last 8 years! You and your team have been an amazing resource for me. I have always been impressed by the knowledge and professionalism of everyone at Focal Point, which is a true testament to your leadership.”

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The Focal Point Research team is ready to help with all of your scientific and regulatory needs.  Our team has the experience and expertise you need to see your product to market and we are eager to help you.

181 Lakeshore Road E. Mississauga, ON

1 (905) 271 2709

mail@focalpointresearch.net