At Canary Regulatory Affairs, we help pharmaceutical, biotech, and medical device companies bring innovative products to market. Our mission is simple: get your product approved to treat patients without unnecessary delays. We provide strategic and hands-on support across every stage of development, from early concept through global regulatory approval. Our team brings deep industry experience and a solutions-first mindset to every engagement. Our expertise spans:

Quality/CMC: formulation, manufacturing process development and validation

Non-Clinical: in vitro/in vivo pharmacology and toxicology study design and oversight

Clinical: study protocol design, investigator brochures, and clinical study reports authoring

We specialize in navigating complex regulatory landscapes. With proven experience working with the FDA, EMA, European National Competent Authorities, and Australia’s TGA, we guide clients in asking the right questions, engaging proactively with agencies, and negotiating effectively.

At Canary, we tailor strategies to your goals, work flexibly with your team, and deliver results with the urgency and care your project deserves.

Why work with us

End-to-End Expertise

We offer integrated support across Quality/CMC, non-clinical, and clinical development, ensuring continuity and coordination across all phases of product development.

Proven Global Regulatory Experience

With direct experience working with the FDA, EMA, European NCAs, and Australia’s TGA, we help clients engage early and effectively with regulators—minimizing delays and maximizing success.

Strategic and Operational Support

We don’t just advise—we execute. Clients benefit from both high-level strategy and hands-on operational support tailored to their development stage and resource constraints.

Solutions-First Mindset

We understand the real-world challenges of drug and device development and focus on pragmatic, actionable solutions that drive progress.

Agile and Collaborative Approach

We act as an extension of your team, offering flexible, responsive support that integrates seamlessly with internal functions and external partners.

Track Record of Accelerating Approvals

Our proactive regulatory strategies are designed to anticipate hurdles and streamline interactions with agencies—getting products to patients faster.

Trusted by Early-Stage Innovators

Our experience working with early-stage companies means we know how to scale support, work within constraints, and build lasting partnerships.