Areas of Expertise
Expertise includes, but is not limited to:
Strategies & Roadmaps
Regulatory intelligence can be defined as analyzing and synthesizing both existing and emerging requirements to create and manage an efficient regulatory roadmap for a specific set of indications, products, markets, and stakeholders. That's a mouthful. Fortunately, that's also what we consider our greatest strength and the cornerstone of our expertise. We're specialized in developing global registration strategies that align with both the strengths and constraints of a given project. We can help you develop a strategy that leverages regulatory requirements and review timelines to optimize your product launch. We can collaborate to determine the testing strategies, protocols, and prioritizations that address your the particular regulatory needs, while fitting within your IOVV. For more information on maintaining this strategy through fluid product lifecycles and regulatory climates, see 'Sustained Regulatory Intelligence' below.
Process Creation & Improvement
Beyond providing advice geared towards a specific scenario or product, Wolf Regulatory also engages clients on a company level to establish, examine, or improve regulatory policies and processes. Often this takes the form of cross-functional projects resulting in improved standard operating procedures (SOPs) that allow a client to improve performance and compliance in product design and lifecycle activities (Design Control), regulatory deliverables (Change Management, Significant Change Assessments, Technical File maintenance), or post-market surveillance activities (Clinical Data Evaluation). We're proficient in working cross-functionally within companies to address the needs of multiple stakeholders (Regulatory, Quality, Engineering, Manufacturing, Sales, etcetera). Additionally, we have familiarity with a wide range of engineering and enterprise software suites, allowing us to embed and effect change quickly and efficiently should such a service be needed.
Sustained Regulatory Intelligence
In addition to providing initial regulatory strategy, Wolf Regulatory Consulting works to ensure clients have access to sustained monitoring of regulatory trends, as requirements, practices, and bureaucratic changes often arise during a product's lifecycle. Anticipating and addressing these regulatory changes can be essential to ensuring your project does not derail. To this end, Wolf Regulatory Consulting offers customized active monitoring of authoritative regulatory information relevant to our client's projects or portfolio, so we can alert and guide when regulatory risks emerge.
US & EU Device Registration
Applications for product registration must be thorough, persuasive, and technically accurate to attain government approval or clearance. At Wolf Regulatory Consulting, we have the unique blend of skills necessary to author a balanced, successful application. We have authored numerous 510(k) submissions and Technical File applications, and are well-versed with less common approaches as well, such as IDEs and the De Novo Classification Process. We also recognize that obtaining product approval or clearance isn't itself sufficient; it needs to be the right approval. Our experience includes Requests for Designation, 513(g) Requests for Information, 510(k) Exemption rationales, and significant change (K97-1) assessments, so you can rest assured your product launches with the appropriate approvals and optimal scope of indications.
Global Device Registration
Beyond US and EU product registration capabilities, we also have proficiency helping clients successfully launch products elsewhere around the globe. We have extensive experience with the other North American Markets, Canada (Health Canada applications and amendments) and Mexico (COFEPRIS product registrations). Additional experience includes work with the following markets and regulatory agencies: Brazil (ANVISA), Colombia (INVIMA), India (DCGI), Japan (PMDA), and Peru (DIGEMID). So whether you're pursuing a traditional or unconventional path to market, we'll remain a strong regulatory partner.
Acquisitions & Partnerships
Purchasing a technology, selling your startup, or entering a new business arrangement? Wolf Regulatory offers due diligence and regulatory strategy services to ensure that the regulatory aspect of your transaction is appropriately addressed. Regulatory support of acquisitions and partnership agreements can include, but is not limited to: Performing due diligence for purchased products' indications, regulatory documentation, labeling, and marketing material; Distributor agreement analysis, including own brand labeling and over-labeling initiatives; Regulatory value appraisal; 510(k) ownership transfer documentation. Regulatory status remains a crucial component of any medical device product or company, and should be examined carefully prior to business transactions.
Clinical Outcomes Analysis
Clinical outcomes and efficacy analysis is rapidly emerging as a crucial component of registrations and renewals. Wolf Regulatory has allocated significant time to honing clinical data analysis skills, developing particular proficiency in generating MEDDEV 2.7/1 revision 4-compliant Clinical Evaluation Reports for Notified Bodies. We are also experienced in assisting with related clinical assessment activities, such as: Risk Management Report (RMR) assessment, complaints dispositioning, Health Hazard Evaluations (HHEs) and related recall assessments. Regulatory requirements don't disappear once your product is launched, but working together we can help ensure sustained success.
Communications Review
The regulatory climate surrounding product labeling remains in a constant state of flux, as agencies refine and iterate expectations regarding appropriate terminology and satisfactory substantiation of claims. We take pride in helping our customers understand the nuanced expectations for their marketing and technical collateral. Communications review capabilities range from providing company-wide or department-specifc training to document review for advertising, instructional, labeling, field notice, or sponsored presentation materials. With our assistance, you can remain confident in the integrity of your labeling materials.
Regulatory Authority Representation
For startups and established companies alike, meetings and teleconferences with the FDA, a Notified Body, or Health Canada can sometimes be a daunting task. At Wolf Regulatory Consulting, we have experience ensuring clients are represented effectively for in-person meetings, formal teleconference interactions, as well as written correspondence. Our focus is on leveraging thorough preparation and individualized coaching to maximize the likelihood of a favorable direction and outcome for any meeting.