Regulatory Affairs Consultants

What is Regulatory Affairs?

Regulatory Affairs (RA) is a scientific and technical discipline ensuring a company meets all of the regulations pertaining to its industry.  It is a complementary role to that provided by the legal department.  RA professionals in cosmetic, food, nutritional supplement, drug and medical device companies will usually be scientists or physicians who can deal with the complex regulatory aspects of their products.  They typically are the front-line contact with regulators such as Health Canada and the US FDA.
Regulatory Affairs can become involved in a project as early as product development, manufacturing, and clinical trials, and can be involved with labeling and claim compliance.  RA is sometimes defined as the “middleman” between the company and the government regulatory agency.
The goal of regulatory affairs professionals is to protect the environment and human health, to ensure products meet regulations on quality, efficacy, and safety, and to ensure product information is accurate and compliant.

Some duties of Regulatory Affairs Consultants include:

Regulatory Affairs:

  • Assisting with product and formulation development by advising R & D regarding laws, regulations, and guidance documents
  • Ensuring formulation, packaging, and product claims are compliant with the country’s regulations
  • Compiling and submitting product registration and notification documents to the government
  • Ensuring compliance of GCP and GLP guidelines, regulations, and laws
  • Filing biannual/annual reports with regulatory agencies

Focal Point Research provides a full suite of regulatory affairs services across the cosmetic, drug, nutritional supplement and medical device industries. As trusted Health Canada and US FDA Regulatory Consultants, we guide clients to the complex regulations in these categories to expedite products getting to market without interruption.

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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