Pharmaceutical Services

Guidance from Strategy to Submission.

For early-stage and growing pharmaceutical companies, navigating global regulatory requirements in Canada, the U.S., and global markets can be complex and overwhelming, particularly without a dedicated in-house regulatory team. SGS Nutrasource provides flexible, expert regulatory support tailored to your company’s stage, needs, and budget. 

Our experienced team helps you build a clear, compliant regulatory roadmap and move your product forward with confidence, whether you need comprehensive, end-to-end support or targeted assistance with specific activities or modules.

Our Service Offerings

Regulatory Strategy & Assessment

  • Product classification (drugs, biologics, OTC drugs, combination products, medical devices)
  • Regulatory Assessment
  • Regulatory Gap Analysis & Roadmap Report
  • Regulatory Strategy & Development Planning

Regulatory Submissions & Lifecycle Management

  • CTAs & INDs
  • NDA/ANDA/BLA
  • NDS/ANDS
  • Rx to OTC Switch
  • 510(k)/De Novo/PMA
  • Medical Device Licence applications
  • CMC documentation
  • Nonclinical & clinical documentation
  • Establishment registration
  • Product registration
  • Post-submission & lifecycle support

Regulatory Agency Interactions

  • Pre-IND
  • Pre-CTA
  • Pre-OMOR
  • Regulatory Meeting Preparation & Participation
  • Agency Correspondence & Responses

Who We Support

We work with a diverse range of organizations at different stages of development, including: 

Startups & Early-Stage Biotech/Pharma Preparing for Clinical Trials  
If you're preparing your first Investigational New Drug (IND) submission or Clinical Trial Application (CTA), our team provides the strategic direction and technical expertise needed to build a strong foundation for successful agency interactions and clinical development.  

Small-to-Mid-Sized Pharmaceutical Companies Without Internal Regulatory Teams  
We support growing pharma organizations that lack in-house regulatory expertise but require experienced guidance to navigate complex regulatory processes efficiently and compliantly.  

Companies Entering New Markets Needing Licensing or Regulatory Guidance  
Expanding into new geographic regions? We help companies understand and meet regional regulatory requirements for U.S. FDA, Health Canada, and other international markets, ensuring a smooth market entry and minimizing unexpected delays.  

Resource-Constrained Teams Requiring Flexible, Scalable Support  
Whether you need end-to-end support or targeted assistance for specific modules or stages of your submission, we provide scalable services that align with your team’s capabilities, resources, and development timeline.  

Want to learn more? Connect with our team to see how our services can meet your needs.

Connect With Our Team