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Canopy offers a complete Regulatory Solution by delivering expert end-to-end Regulatory Affairs and Regulatory Operations services for biotechnology, pharmaceutical, and medical device companies from early product development to commercialization and beyond.
At Canopy, our world-class team of dedicated and experienced Regulatory Affairs and Regulatory Operations subject matter experts provide an unparalleled level of customer service to assist clients in meeting complex challenges in an evolving environment of product development and commercialization. With a combination of technical expertise, industry experience and business-focus, our Regulatory Solutions team works closely with clients worldwide to deliver high-quality innovative solutions, setting up our clients for success as they navigate the complex global regulatory landscape. We pride ourselves on our flexibility and can offer ad-hoc coverage, part time coverage to full time coverage.
Meet the Team
Jennifer Harakal
Jennifer Harakal
Head of Regulatory Affairs
Jasbir Chohan
Jasbir Chohan
Head of Regulatory Operations

Our Offerings


Global Regulatory guidance and advice, leadership and informed insight to set and implement successful Regulatory strategies to all stages of product development, gap assessments of existing product development programs, Regulatory roadmaps, strategies for special designations and accelerated pathway approaches, coaching and preparation for communication and interactions with Health Authorities, and assistance with Regulatory submission planning and authoring.


Strategic development and execution of Global CMC content from preparation to review for submission to Health Authorities and the management of related responses.

CTR & CTIS Support

Comprehensive support for implementation of the EU Clinical Trial Regulation 536/2014 from consultancy and training to uploading your Part 1 and Part 2 documents as an extension of your in-house team. From CTR compliance, implementation, and advisory services to operational support in CTIS, our team ensures that your EU clinical trial submissions are made in a timely and efficient manner through CTIS. Our services include redaction and deferral strategy & support, project management, compilation, validation, and substantial modification management, ensuring compliance & regulatory efficiency throughout the clinical trial.

Ad Promo Review

Global experience with the review and approval of promotional materials (drugs, biologics, medical devices), launch planning, advisory comment and interactions with OPDP/APLB. Expert leadership in the development and/or review of procedures and workflows, as well as ongoing analysis of industry trends. Our experienced and collaborative ad promo consultants help clients meet their goals with a balanced approach to achieving business needs while maintaining compliance with industry standards and regulations.

eCTD Submissions & Lifecyle Management

We offer comprehensive support for eCTD submissions. Our approach is based on ongoing collaboration and knowledge transfer, ensuring that you and your team are fully prepared and compliant with the latest eCTD regulatory requirements. With 24x7 operations, our team ensures that submissions are made in a timely and efficient manner. We have well-defined processes in place to continually improve consistency, efficiency, quality control, and risk mitigation. Our services include eCTD submission strategy, project management, compilation, validations, submissions via gateway, and lifecycle submission management to ensure compliance throughout the product's lifecycle.


Expert guidance on the creation and implementation of global labeling strategies for the development and commercialization of pharmaceutical, biotech and medical device products. Focused leadership in the creation and/or review of labeling procedures and associated workflows, and in the management/support of label content with Health Authorities.

Word & PDF Publishing, CTD Templates

Our services for Word formatting and publishing documents ensure that your submission documents meet the eCTD PDF specification requirements and are prepared in a way that makes them easy to navigate and review. We take care of the technical details so that you can focus on the content of your document. The CTD Word template suite is designed to simplify the process of creating compliant submission documents, allowing clients to focus on the content rather than formatting. With a common structure and an easy-to-use toolbar, the templates enable users to quickly apply commonly used styles. By implementing the template suite, authors can streamline the process, ensure consistent formatting, and save time and effort.

Canopy's Regulatory team has a focus and passion for cultivating relationships and helping clients achieve their goals.
Years of Management Experience
Project Engagements
Submissions with 100% Approvals
“Thank you to the Canopy team for assisting us with our recent NDA approval. Your insights, calmness and organization were instrumental in navigating a path to this milestone. We are truly thankful that you are part of our extended regulatory team and we look forward to further collaboration on our other projects.”

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Regardless of where you are in your journey, we can help you achieve optimal success.
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