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 focus on delivering strategic and innovative solutions in a time-sensitive manner.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Assisting with post-marketing changes and providing Good Manufacturing Practices (GMP) and Quality System services.
* Maintaining currency with Health Canada guidelines and regulations, operating in electronic CTD format (eCTD) and participating in 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.
* Supporting foreign companies in establishing quality assurance systems and regulatory affairs departments for operations in Canada.
* Facilitating Drug Establishment Licences (DELs) and chaperoning 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) is a Canadian consulting firm established in 2001, specializing in obtaining regulatory approvals from Health Canada. They focus on delivering strategic and innovative solutions in a time-sensitive manner.
**Expertise & scope**
* Obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices.
* Assisting with post-marketing changes and providing Good Manufacturing Practices (GMP) and Quality System services.
* Maintaining currency with Health Canada guidelines and regulations, operating in electronic CTD format (eCTD) and participating in 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.
* Supporting foreign companies in establishing quality assurance systems and regulatory affairs departments for operations in Canada.
* Facilitating Drug Establishment Licences (DELs) and chaperoning 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 Canadian regulatory submissions. They have experience with various product types, including pharmaceuticals, natural health products, and medical devices. Their services extend to ensuring compliance with Good Manufacturing Practices (GMP) and establishing quality systems. RSI also supports foreign entities looking to establish operations in Canada, including obtaining Drug Establishment Licences (DELs) and managing Health Canada audits. They are equipped to handle electronic submissions and are involved in Health Canada's electronic submission gateway pilot program.
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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Experience in obtaining 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 Canadian operations.
Source
“RSI has helped over twenty companies to obtain Drug Establishment Licences (DELs) for operations in Canada”
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Participates in Health Canada's Common Electronic Submissions Gateway (CESG) pilot program.
Source
“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.
Source
“Regulatory Solutions Inc. (RSI), founded in 2001, obtains strategic and innovative Regulatory Affairs approvals from Health Canada in a time sensitive manner.”
Buyer Snapshot
Best for
- Canadian market entry for pharmaceuticals, natural health products, and medical devices.
- Companies seeking GMP and Quality System support.
- Foreign companies establishing operations in Canada.
How engagement typically works
- Strategic regulatory planning.
- Compliance support.
- Audit facilitation.
Typical deliverables
- Health Canada approval submissions.
- Drug Establishment Licences (DELs).
- Quality assurance system setup.
- GMP audit support.
Good to know
- Primarily focused on Canadian regulatory approvals.
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
No
Recall Support
No
Inspection Support
Yes, Health Canada GMP audits
Emergency Contact24x7
No
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