Regulatory Affairs Consulting – We Know FDA & We’re Here To Help

Regulatory Affairs Consulting Services – the “Snow” Advantage

Our Regulatory Affairs consulting services include the following:

Up-to-date

We are Regulatory consultants who are up-to-date with current Regulatory changes.

Seasoned, Experienced & Efficient

With over 32 Years experience, We know what it takes to get the job done.

Ideal Strategy

We design the most ideal Regulatory Affairs Strategy with you.

We Hit The Ground Running!

We’ve been here before- No Training Needed- No Long Explanations. Just the Ability to quickly Assimilate to Your Team and begin contributing.

Wisdom in Working with FDA

We draw from a vast experience with FDA to focus on what they will deem important and not important. We know what they’re looking for and can pass this on to keep our eye on the bullseye for you.

Don’t Need Long Training Before We Begin

We can start contributing day 1

Thoughtful Pragmatic Strategic Discussion

There’s is often more than 1 way to get to the destination you need. We can quickly and efficiently present this discussion with you in order to achieve the best outcome for you.

SNOW CONSULTING brings 32 years of Regulatory and Pharmaceutical experience to bear in strategic solutions for the consumer. With work in all areas of the drug development process from the IND on through Post-Marketing, SNOW CONSULTING can guide you toward successful development of your product, through a robust Regulatory Strategy. This includes exploring expedited approval pathways, coordinating Health Authority interactions, review of documents, labeling strategy, Regulatory Risk Management, and helping to set-up a Regulatory Department where needed, including creating SOPs and procedures.

Have you got a project or study that requires skilled regulatory staff urgently?

Snow Consulting delivers regulatory affairs consulting services to our clients for the development and FDA approval of IND’s (investigational new drugs), biologics, drug delivery technology (biotechnology products) and combination products:

REGULATORY AFFAIRS SERVICES

REGULATORY SUBMISSION FORECAST AND PLANNING

SUBMISSION DOCUMENT MANAGEMENT AND TRACKING

REGULATORY CONTENT MANAGEMENT

CHANGE CONTROL MANAGEMENT

TRACKING LABEL CHANGES

INTEGRATING REGULATORY INFORMATION

REGULATORY STRATEGY

GLOBAL EXPERIENCE

Early through late stage development

Lifecycle management

Clinical trial planning and protocol review

PATHWAY ASSESSMENT

Orphan Design

Pediatric

Fast Track

Breakthrough therapy designation

Priority review and accelerated approval

HEALTH AUTHORITY PREP

Pre-IND/CTA

End of Phase 2

Pre-NDA/BLA

Late-Cycle meetings

US and ex-US

REGULATORY CMC

CMC STRATEGY AND EXECUTION

Developing CMC strategy

GLOBAL AND LOCAL EXPERIENCE

Driving final content in CMC sections submitted to health authorities

HEALTH AUTHORITY INTERACTIONS

Lead interactions relative to CMC issues

Pre-IND

End of Phase 2

Pre-NDA

Late-Cycle Meetings

FUNCTIONAL LEADERSHIP

Representing CMC on cross-functional teams

Regulatory intelligence, relative to CMC

Cutting edge knowledge of FDA guidelines

Proactive identification of issues, escalation to management as appropriate

Regulatory Affairs Consulting Labeling

Snow Consulting

Navigating the Regulatory Landscape: Our Comprehensive Regulatory Affairs Consulting Services

In the intricate world of business, especially within industries such as pharmaceuticals, biotechnology, medical devices, and food and beverages, adherence to regulatory standards is not just crucial—it’s non-negotiable. From product development to market entry and beyond, navigating the complex maze of regulations demands expertise, foresight, and meticulous attention to detail. This is where regulatory affairs consulting services become indispensable.

At Susan Snow Consulting LLC, we specialize in providing comprehensive regulatory affairs consulting services tailored to meet the unique needs of our clients. Our team comprises seasoned regulatory experts with a deep understanding of global regulatory requirements and a proven track record of guiding companies through regulatory challenges to achieve compliance efficiently and effectively.

Understanding the Regulatory Landscape

Navigating the regulatory landscape can be daunting, with regulations varying significantly across different regions and industries. Our experts possess an in-depth understanding of regulatory frameworks worldwide, including the FDA in the United States, the European Medicines Agency (EMA) in Europe, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and many others.

Customized Regulatory Strategies

We recognize that every product and every client is unique. That’s why we don’t believe in one-size-fits-all approaches. Our consulting services are tailored to each client’s specific needs, whether they are launching a new product, seeking regulatory approval for market entry, or facing compliance challenges.

Product Development Support

From the conceptualization phase to commercialization, our regulatory affairs consultants work closely with clients to integrate regulatory considerations seamlessly into the product development process. By proactively addressing regulatory requirements early on, we help minimize delays and mitigate risks, ultimately expediting time to market.

Regulatory Submissions and Approvals

Preparing and submitting regulatory dossiers can be a time-consuming and complex process. Our experts have the knowledge and experience to streamline this process, ensuring that submissions are accurate, complete, and compliant with relevant regulations. Whether it’s a new drug application (NDA), a premarket approval (PMA) application, or a technical file for CE marking, we guide our clients through every step of the submission and approval process.

Compliance and Post-Market Surveillance

Regulatory compliance doesn’t end once a product is on the market—it’s an ongoing commitment. Our consultants provide support in maintaining compliance through post-market surveillance activities, including adverse event reporting, quality management system audits, and regulatory inspections. By staying vigilant and proactive, we help our clients safeguard their products and maintain regulatory compliance in an ever-evolving landscape.

Global Expansion Strategies

Expanding into new markets brings both opportunities and challenges, particularly from a regulatory perspective. Our consultants assist clients in developing robust strategies for global market expansion, navigating the complexities of international regulations, and obtaining the necessary approvals to enter new markets successfully.

Training and Education

Knowledge is power, especially in regulatory affairs. We offer training and educational programs to empower our clients with the knowledge and skills they need to navigate the regulatory landscape independently. From customized workshops to online courses, we equip teams with the tools and insights necessary to achieve regulatory compliance and drive business success.

We Know FDA – Let us be your partner in regulatory excellence!

In today’s highly regulated environment, compliance is not just a legal requirement—it’s a strategic imperative. At Susan Snow Consulting LLC, we understand the challenges that companies face in navigating the regulatory landscape, and we’re here to help. With our comprehensive regulatory affairs consulting services, we empower our clients to achieve regulatory compliance, accelerate time to market, and navigate the path to success with confidence. Let us be your partner in regulatory excellence.