We bring structure from the start, so your development program is executed with purpose and your FDA review is navigated with confidence.
We help you manage your products and facilities to meet rigorous FDA quality and manufacturing standards.
We shape your path through the shifting regulatory policy environment.
We navigate a complex regulatory landscape to inform some of the most high-stakes decisions in the life science space.
With firsthand insight into the FDA’s decision-making precedents and expectations, we anticipate complexity, address challenges, and shape strategies to advance your product through approval and post market.
Canal Row has multidisciplinary expertise to support drug and biologics sponsors across a range of therapeutic areas, patient populations, product types, and technologies.
Our guidance relies on the latest clinical and regulatory science to optimize your development program and lay the foundation for an efficient and successful FDA review.
We are experts in effective communication with regulators, from early interactions to responding to FDA requests for information.
We help clients prepare for end-of phase 2, pre-filing, mid-cycle, and end-of-review meetings with FDA staff.
When an NDA or BLA is facing an FDA advisory committee, we prepare sponsors with strategies for a successful outcome.
We assist sponsors in navigating the specialized regulatory requirements and pathways related to biodefense-specific products.
We advise sponsors on strategies for resolving scientific and regulatory disputes with the Agency and help prepare requests for formal dispute resolution.
Beginning in the development stage, we design a proactive labeling strategy and support it with review of proposed labeling language and guidance on negotiating potential revisions with FDA reviewers.
With our insight into trends in the R&D model and other influences across the industry, we can advise companies regarding potential regulatory risks and opportunities to inform their strategic planning and prioritization of drug development pipelines.
We advise on technical and strategic elements of designing clinical trials, including innovative trial designs and considerations for rare diseases.
We provide insight on the qualification, validation, and use of drug development tools, from the established (biomarkers, clinical outcomes assessments) to the novel (technologies qualified through ISTAND, new approach methodologies for preclinical testing).
We assist sponsors in developing requests for breakthrough therapy designation, regenerative medicine advanced therapy designation, fast track, priority review, accelerated approval, or orphan drug designation.
Our guidance helps companies optimize the use of real-world data for evidence generation and incorporate RWE into their pre- and post-market regulatory strategies.
We anticipate FDA requirements for post-market studies and commitments, as well as risk evaluation and mitigation strategies (REMS), and develop strategies for designing post-market programs.
Both pre- and post-market, we counsel clients on the regulation and FDA guidance for compliant product promotion, including use of social media, direct-to-consumer marketing, physician communications, scientific exchange, and investor communications.
We advise on requirements for drug safety monitoring and reporting, strategies for pharmacovigilance and risk management, and changes to product labeling.
Canal Row provides strategic support for designing, implementing, and maintaining quality systems that align with regulatory requirements across the GxP spectrum, from GCP to GMP.
We identify opportunities to strengthen and reinforce practices that will reduce risk and instill a culture of quality and patient and consumer safety.
As companies pursue increasingly specialized treatments with smaller patient populations, we help ensure that nuanced compliance standards are met and manufacturing capabilities are robust and sustainable.
We guide clients’ strategy for responding to regulatory actions (483 observations, warning letters, untitled letters), supporting fluent, productive communication with the FDA until issues are resolved.
We translate our extensive experience conducting and leading inspections across all FDA program areas into strategies that build quality and preparedness into clients’ operations from the beginning, so that your people and processes are in an ongoing state of readiness.
We prepare your team for GxP audits with technical advice, mock audits, and training on key quality systems.
We assist clients with the design and validation of new facilities to ensure compliance with FDA’s regulatory requirements. This includes site visits, remote reviews, and consulting on pre-operational reviews, and FDA’s PreCheck Pilot To Strengthen Domestic Supply Chain.
We support the development of SOPs, protocols, and reports with technical and strategic guidance and review.
We assist firms in developing, implementing, and documenting robust corrective action plans in response to regulatory findings, focused on identifying root causes to support remediation that withstands regulatory scrutiny.
We evaluate clients’ supply chain validation practices and help design processes that leverage advanced technology and promote adaptability and efficiency while reinforcing compliance and quality.
We share our clients’ priorities of protecting patient and consumer safety and surpassing standards for product quality. Through practical guidance on maintaining regulatory compliance and strategies that instill quality as a fundamental operating principle, we help clients fulfill that mission.
Across multiple programs, we assist firms in navigating the FDA import alert process, including both countrywide and product-specific import alerts, and in drafting petitions to lift restrictions on a firm’s ability to import products into the U.S.
We assist with manufactured foods, cell-cultured meat, and fresh produce, including food safety plans, HACCP plans, dietary supplements, and other FSMA compliance requirements.
We support cosmetic manufacturers and importers by advising on FDA regulatory requirements, including product safety, labeling, facility considerations, and import compliance. Our approach helps clients anticipate FDA concerns, proactively address gaps, and maintain inspection-ready compliance that protects both market access and brand credibility.
Canal Row supports the policy needs of a diverse range of clients.
Small & Mid-Size Biotechs Companies with limited regulatory experience or capacity rely on our services to better understand and navigate FDA regulation and policies broadly and in relation to their own development programs.
Large Pharmas Regulatory affairs leaders seek our expertise to help them evaluate and respond to specific policy issues.
FDA Stakeholders Trade associations, patient organizations, policy consortia, and other stakeholders collaborate with us to refine their education and advocacy efforts.
We help clients stay informed of and aligned with the latest developments in FDA regulation and policy and work with stakeholders to shape the Agency’s regulatory policies and priorities.
We monitor and analyze new regulation, guidance, and policy initiatives from the U.S. FDA and its international partners, helping clients stay ahead of changes in the regulatory landscape.
Our guidance enables organizations to adapt to regulatory changes and incorporate FDA policy initiatives into their activities and strategic planning. Further, we work with clients to shape policy from the FDA and related agencies as proposals develop, through participation in public meetings or expert working groups and submission of comments.
We assist stakeholders in understanding and effectively commenting on new FDA guidance and regulation.
When innovative products raise questions of product classification and regulatory jurisdiction, we help clients engage early with the FDA to navigate the gray areas—whether a product will be classified as a drug, biologic, device, or combination product, or whether it is an emerging technology that requires a novel regulatory approach—reducing uncertainty and keeping development on track.
For developers and users of novel research and development tools and emerging technologies, we advise on regulatory considerations and opportunities such as participation in FDA pilot programs.
We offer strategic consultation on user fee program negotiations and implementation.
We craft communications and engagement strategies that promote constructive exchange of ideas with the FDA and other stakeholders and facilitate coalition-building.
Canal Row navigates the complex FDA regulatory landscape to inform high-stakes decisions in the life sciences space.
We review the company’s regulatory history and correspondence with FDA, clinical trial data, proposed trial protocols, history of compliance with regulations and quality standards, manufacturing capabilities, and FDA inspection findings, generating a comprehensive picture of the regulatory outlook.
When pre-market review involves an FDA advisory committee meeting, we identify issues that may affect the committee’s recommendations and provide insight into how the FDA might weigh committee input.
Our assessment accounts for the effects of the competitive landscape, broader industry trends, and an evolving regulatory environment.
We design a strategy for how the target company can best deploy new capital to advance the program(s) in question and optimize the potential for a successful regulatory outcome.
We advise litigators representing FDA-regulated clients in a wide variety of matters (complex commercial litigation, unfair competition and false advertising cases, intellectual property litigation, product liability class actions, tax litigation, and securities class actions) and provide consulting and expert testimony.
We support public affairs teams and advocacy organizations with in-depth analysis of statutory and regulatory frameworks, regulatory trends, and agency guidance to strengthen advocacy strategies and policy positions.