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 assist companies with strategic regulatory planning, compliance support, and post-marketing changes.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Providing Good Manufacturing Practices (GMP) and Quality System services.
* Navigating electronic CTD format (eCTD) submissions and participating in Health Canada's 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.
* Assisting foreign companies in establishing operations in Canada, including setting up quality assurance systems and obtaining Drug Establishment Licences (DELs).
* Supervising GMP audits by Health Canada for Canadian facilities.
* Serving clients in the United States, India, China, and Europe for Canadian regulatory approvals.
**Reputation / proof points**
* Founded in 2001.
* Assisted over twenty companies in obtaining Drug Establishment Licences (DELs).
Regulatory Solutions Inc. (RSI) is a Canadian consulting firm established in 2001, specializing in obtaining regulatory approvals from Health Canada. They assist companies with strategic regulatory planning, compliance support, and post-marketing changes.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Providing Good Manufacturing Practices (GMP) and Quality System services.
* Navigating electronic CTD format (eCTD) submissions and participating in Health Canada's 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.
* Assisting foreign companies in establishing operations in Canada, including setting up quality assurance systems and obtaining Drug Establishment Licences (DELs).
* Supervising GMP audits by Health Canada for Canadian facilities.
* Serving clients in the United States, India, China, and Europe for Canadian regulatory approvals.
**Reputation / proof points**
* Founded in 2001.
* Assisted over twenty companies in obtaining Drug Establishment Licences (DELs).
Additional information
Regulatory Solutions Inc. focuses on guiding clients through the complexities of Health Canada's regulatory landscape. Their services extend to ensuring compliance with Good Manufacturing Practices (GMP) for both imports and distributors. They are adept at managing post-marketing changes and maintaining up-to-date knowledge of Health Canada's evolving guidelines and regulations. RSI's experience includes facilitating electronic submissions and supporting companies looking to establish a presence in Canada, including the setup of necessary quality systems and obtaining establishment licenses.
Key Highlights
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Founded in 2001, providing 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
“Regulatory Solutions Inc. is a Canadian consulting firm specializing in obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.”
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Assisted over twenty 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”
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Experienced in electronic CTD format and 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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Established in 2001, demonstrating long-term industry presence.
Source
“Regulatory Solutions Inc. (RSI), founded in 2001, obtains strategic and innovative Regulatory Affairs approvals from Health Canada”
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 execution.
- Compliance support and quality system implementation.
Typical deliverables
- Health Canada regulatory approvals.
- Drug Establishment Licences (DELs).
- Quality assurance system setup.
- GMP audit supervision.
Good to know
- Best when focused on Canadian market regulatory affairs.
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 approvals and licenses.
Recall Support
No
Inspection Support
Supervises GMP audits by Health Canada.
Emergency Contact24x7
No
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