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) is a Canadian consulting firm established in 2001, specializing in obtaining regulatory approvals from Health Canada. They have experience assisting clients in the United States, India, China, and Europe with Canadian regulatory submissions.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Strategic regulatory planning and compliance support.
* Assistance with post-marketing changes.
* 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.
* Chaperoning and supervising Health Canada GMP audits of Canadian facilities.
**Reputation / proof points**
* Founded in 2001.
Regulatory Solutions Inc. (RSI) is a Canadian consulting firm established in 2001, specializing in obtaining regulatory approvals from Health Canada. They have experience assisting clients in the United States, India, China, and Europe with Canadian regulatory submissions.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Strategic regulatory planning and compliance support.
* Assistance with post-marketing changes.
* 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.
* Chaperoning and supervising Health Canada GMP audits of Canadian facilities.
**Reputation / proof points**
* Founded in 2001.
Additional information
Regulatory Solutions Inc. focuses on navigating Health Canada's regulatory landscape, particularly for pharmaceuticals, natural health products, and medical devices. They emphasize a time-sensitive approach to obtaining approvals and maintaining compliance. Their services extend to post-marketing activities and quality systems, including GMP. RSI is equipped to handle electronic submissions and has experience with various Health Canada processes, such as Drug Establishment Licences and GMP audits. They also support foreign companies looking to establish operations in Canada.
Key Highlights
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Founded in 2001, providing regulatory solutions for over two decades.
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”
Certifications & Trust Signals
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Experience with electronic submissions and Health Canada's Common Electronic Submissions Gateway (CESG).
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.”
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Provides support for 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.”
Buyer Snapshot
Best for
- Canadian market entry for pharmaceuticals, natural health products, and medical devices.
- Companies seeking Health Canada approvals and GMP compliance.
How engagement typically works
- Strategic regulatory planning and support.
- Assistance with regulatory submissions and audits.
Typical deliverables
- Health Canada regulatory approvals.
- Drug Establishment Licences (DELs).
- Quality assurance system setup.
- GMP audit support.
Good to know
- Best when focused on the Canadian regulatory market.
HQ:
Caledon, Canada
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
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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:
drugs, devices
Service Types:
US Agent Services, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Registration Support:
Yes
Additional us_agent_fda Details
Product Types
Pharmaceuticals, Natural Health Products, Medical Devices
Registration Support
Implied through obtaining Health Canada approvals and DELs.
Recall Support
No
Inspection Support
Support and coordination for Health Canada GMP audits.
Emergency Contact24x7
No
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