Regulatory Strategy & Compliance

What is Regulatory Strategy & Compliance?

Regulatory strategy and compliance play a pivotal role in the success of life sciences startups. Our team excels in providing targeted guidance and support, ensuring your life sciences venture aligns with best practices and regulatory standards, bolstering its reputation and instilling trust among investors and stakeholders. Through meticulous execution, we help you navigate the intricate regulatory requirements and filings of specific therapeutic areas for the health regulatory body of your choosing, positioning your organization as a reliable and compliant player in the industry.

Key Focus Areas:

Tailored Regulatory Plans: We work with you to customize a regulatory strategy to determine a pathway for the class of your pharmaceutical, medical device, diagnostic, natural health product, or related products.
Regulatory Filing Solutions: Our compliance experience includes preparing domestic and international regulatory applications and facilitating submissions to the health regulator, providing you with end-to-end support throughout the entire product lifecycle.
Regulatory Intelligence: API remains updated on the latest regulatory developments to provide proactive and informed strategies for regulatory compliance.

Benefits of Regulatory Strategy & Compliance

In a landscape where compliance is paramount for safe and successful health outcomes, partnering with API for your life sciences regulatory strategy brings several advantages:

Regulatory Confidence: You not only have a partner to navigate complex regulations, but also to help build confidence among your stakeholders and investors, knowing your regulatory strategy is compliant with national and international regulations and relevant GxP standards.
Risk Mitigation: Work with us to proactively identify and mitigate risks, safeguarding your products and ensuring regulatory success.
Faster Product Approvals: Our proactive regulatory strategies streamline your submissions, as our team finds and navigates the right pathways to expedite the approval process for new drugs, medical devices, and natural health products.
Safety & Integrity: From patient safety to data integrity, API’s team of SMEs prioritizes ethical compliance. We are committed to adhering to ICH guidelines, and you can rest assured our regulatory solutions follow Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) standards, and more.
Collaborative Success: We respond to regulatory queries and address concerns raised by health regulatory bodies during the review process. This includes liaising with regulatory agencies such as the FDA, EMA, MHRA, Health Canada and others.
Market Access: Leverage our regulatory expertise to help realize the commercialization of your products in North America, with our track record and experience in Canada and the US.