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Whether you're preparing for your first agency meeting or need strategic guidance to strengthen your submission, we are ready to help you move forward with confidence.

Develop your regulatory strategy ahead of key agency meetings.
Prepare comprehensive briefing packages to address regulator questions.
Maximize the value of your pre-IND or pre-CTA meeting with agency insights.

Pre-IND / Pre-CTA Consultation Preparation (FDA & Health Canada)

Author, review, and submit full or partial modules based on your needs.
Provide ongoing strategic support through every stage of your clinical trial application process.
Ensure compliance with FDA and Health Canada requirements for IND, CTA, NDA, BLA, and NDS submissions.

IND and CTA Development & Submissions (Complete or Modular Support)

Preliminary Regulatory Assessments, Gap Analyses & Roadmap Reports

Identify regulatory gaps early to minimize costly delays.

Receive a clear, actionable roadmap customized for your product and market entry goals.

Access ongoing strategic consulting as your program evolves.

End-to-End Regulatory Support for Pharma and Biotech – Emerging and Established

Simplifying Regulatory Pathway So You Can Focus on Innovation

For early-stage and growing pharmaceutical companies, navigating global regulatory requirements can be overwhelming, especially without a dedicated in-house team. SGS provides flexible, expert regulatory support tailored to your stage, needs, and budget.

Our experienced team helps you build a clear, compliant roadmap to regulatory success, whether you need full-service support or assistance with specific modules.

SGS is the world’s leading Testing, Inspection & Certification company. Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability. We proudly deliver expert services through the SGS name and trusted specialized brands including SGS Nutrasource over a network of 2,500 laboratories across 115 countries.

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Deep expertise across U.S., Canadian, and global regulatory frameworks

Who We Help

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.

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.

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.

Why Partner with SGS?

Flexible support tailored to your program — from full-service submissions to targeted consulting

Proven track record of helping emerging companies advance confidently through clinical and regulatory milestones