Regulatory Solutions Inc
Regulatory Solutions Inc.
Regulatory Solutions Inc. is a Canadian consulting firm specializing in obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices. They offer strategic regulatory planning and compliance support.
Founded in 2001, Regulatory Solutions Inc. (RSI) is a Canadian pharmaceutical regulatory approval and compliance consulting company with extensive success in obtaining Health Canada approvals. They specialize in prescription drugs, natural health products, and medical devices, ensuring timely approvals through strategic planning and expert submission support. RSI's team of consultants possesses diverse skills and a strong track record for navigating Health Canada's requirements, including electronic CTD format and the Common Electronic Submissions Gateway (CESG). They assist clients with new and generic drug approvals, Class II, III, and IV medical device applications, and natural health product submissions. Beyond initial approvals, RSI provides ongoing support for post-marketing changes, Good Manufacturing Practices (GMP), and Quality System services. They also help companies establish regulatory affairs departments and quality assurance systems in Canada, and supervise GMP audits by Health Canada. Their expertise extends to advising on regulatory compliance issues and creating Standard Operating Procedures (SOPs).
About
**Who they are**
Regulatory Solutions Inc. (RSI), founded in 2001, is a Canadian consulting firm specializing in obtaining Health Canada approvals. They provide strategic regulatory planning and compliance support.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Assisting with post-marketing changes.
* Providing Good Manufacturing Practices (GMP) and Quality System services.
* Experience with electronic CTD format (eCTD) and the Common Electronic Submissions Gateway (CESG) pilot program.
* Securing approvals for new and generic drugs, Class II, III, and IV medical devices, and natural health products.
* Setting up and administering quality assurance systems and regulatory affairs departments for foreign companies.
* Assisting companies in obtaining Drug Establishment Licences (DELs) for Canadian operations.
* Supervising GMP audits by Health Canada.
* Serving clients in the United States, India, China, and Europe for Canadian regulatory approvals.
**Reputation / proof points**
* Founded in 2001.
Regulatory Solutions Inc. (RSI), founded in 2001, is a Canadian consulting firm specializing in obtaining Health Canada approvals. They provide strategic regulatory planning and compliance support.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Assisting with post-marketing changes.
* Providing Good Manufacturing Practices (GMP) and Quality System services.
* Experience with electronic CTD format (eCTD) and the Common Electronic Submissions Gateway (CESG) pilot program.
* Securing approvals for new and generic drugs, Class II, III, and IV medical devices, and natural health products.
* Setting up and administering quality assurance systems and regulatory affairs departments for foreign companies.
* Assisting companies in obtaining Drug Establishment Licences (DELs) for Canadian operations.
* Supervising GMP audits by Health Canada.
* Serving clients in the United States, India, China, and Europe for Canadian regulatory approvals.
**Reputation / proof points**
* Founded in 2001.
Additional information
Regulatory Solutions Inc. assists companies in navigating the complexities of Health Canada regulations. Their services extend to ensuring compliance with Good Manufacturing Practices (GMP) for both imports and distributors. They have a proven track record of obtaining various types of approvals, including drug establishment licenses and medical device clearances. RSI also supports foreign companies looking to establish operations in Canada by helping them set up necessary quality systems and regulatory affairs departments.
Key Highlights
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Founded in 2001, Regulatory Solutions Inc. has extensive experience in Canadian regulatory affairs.
Source
“Regulatory Solutions Inc. (RSI), founded in 2001, obtains strategic and innovative Regulatory Affairs approvals from Health Canada in a time sensitive manner.”
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Specializes in obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
Source
“In addition, we have obtained Class II, III and IV medical device approvals as well as natural health products (vitamins, minerals).”
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Assists foreign companies in obtaining Drug Establishment Licences (DELs) for operations in Canada.
Source
“RSI has helped over twenty companies to obtain Drug Establishment Licences (DELs) for operations in Canada as well as chaperoned and supervised a variety of GMP audits by Health Canada of Canadian facilities.”
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Operates with electronic CTD format and participates in Health Canada's Common Electronic Submissions Gateway (CESG) pilot program.
Source
“We are now operating in electronic CTD format (eCTD) for multiple submission types and have joined the pilot program for the Common Electronic Submissions Gateway (CESG) at Health Canada.”
Certifications & Trust Signals
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Provides Good Manufacturing Practices (GMP) and Quality System services.
Source
“We also assist in your company's post-marketing changes and provide excellent Good Manufacturing Practices (GMP) and Quality System services.”
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Has experience serving clients in the United States, India, China, and Europe for Canadian regulatory approvals.
Source
“Our team of associates has also served clients in the United States, India, China, and Europe in obtaining Canadian regulatory approvals.”
Buyer Snapshot
Best for
- Canadian market entry for pharmaceuticals and medical devices
- Companies seeking Health Canada approvals
- Foreign companies establishing Canadian operations
How engagement typically works
- Strategic regulatory planning
- Compliance support
- Post-marketing change assistance
Typical deliverables
- Health Canada approval submissions
- Drug Establishment Licences (DELs)
- Quality assurance system setup
- GMP audit supervision
Good to know
- Primarily focused on Canadian market regulations
HQ:
Caledon, Canada
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD, Food & Beverage
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Inspection Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Additional us_agent_fda Details
Product Types
Pharmaceuticals, Natural Health Products, Medical Devices
Registration Support
Yes
Recall Support
No
Inspection Support
Yes, supervision of GMP audits
Emergency Contact24x7
No
