Snow Mountain Solutions LLC

Driving Innovation Through Regulation

Snow Mountain Solutions LLC is a specialized, U.S.-owned regulatory consulting group that provides comprehensive regulatory and CMC guidance to pharmaceutical, biotechnology, and medical device companies. We offer strategic and operational support throughout the entire product lifecycle, from initial development to post-market activities. Led by Dr. Doris Snow, our team consists of experienced technical and regulatory professionals, with expertise in managing complex pathways and innovative technology platforms across a wide range of product types and indications. Our mission is to help you navigate the intricate landscape of regulatory strategy and dossier preparation and management, thus ensuring timely access to new technology and medicines for patients.

Core Services

Strategic regulatory support tailored to each stage of product development, from early planning to post-market lifecycle management.

Regulatory Strategy Development

We develop personalized roadmaps for pharmaceuticals, biologics, devices, and combination products considering the current global regulatory landscape. This comprehensive plan integrates clinical, nonclinical, and manufacturing development activities, identifies potential issues, and outlines key interactions and submissions with regulatory agencies. A sound regulatory strategy minimizes risk, reduces time to market and ensures that products comply with regulations and industry standards.

Submission Preparation & Management

Our experienced team can author, compile, and manage eCTD compliant INDs, NDAs, BLAs, CTAs, DMFs and global dossiers with Phase appropriate technical content. Our end-to-end project management capabilities ensure timely, accurate and complete submissions resulting in fewer Health Authority inquiries.

Health Authority Interactions

Health Authority interactions ensure that you achieve your product development goals. Let us help with meeting strategy, briefing document preparation, pre-meeting activities such as coaching and rehearsals, and attend meetings to facilitate clear two-way dialogue with authorities.

Quality & Regulatory Compliance Support

Many innovator companies work in a virtual environment leveraging external partners for manufacturing and testing. We will work with your team to ensure GxP readiness by developing policies and procedures to establish programs for auditing, product release, and supplier qualification. With our extensive experience working in virtual companies and in CDMOs, we are positioned to identify gaps in CMC strategy to avoid common pitfalls in product development.

Regulatory Intelligence & Policy Monitoring

We monitor evolving regulations, standards and guidelines to inform proactive strategies. Our regulatory intelligence anticipates regulatory changes, mitigates risks, capitalizes on opportunities for agency interactions, and speeds product development.

Our Team

Our team of regulatory professionals each have >25 years of biomedical industry experience spanning manufacturing, quality control, quality assurance and regulatory affairs. Unlike consulting teams assembled ad hoc from a large company, our small team has decades of shared experience. We operate as a unified extension of your team, ensuring that every deliverable reflects the depth and consistency of our combined expertise.

Doris Snow, Ph.D.

dsnow@snowmts.com

Owner & Executive Regulatory Consultant for Snow Mountain Solutions, specializing in global regulatory strategy for a wide range of biomedical products, including biologics, vaccines, combination products, pharmaceuticals, and medical devices. She is known for her ability to identify and close critical development gaps, accelerate timelines, and align regulatory pathways with business objectives. Her team has successfully authored and managed regulatory dossiers for U.S. and international markets and regularly engages with health authorities to ensure compliance and facilitate market access. She has managed regulatory and clinical development teams, providing executive leadership for over a decade with 30+ years of experience in science. Driven by a commitment to patient access and innovation, Dr. Snow brings strategic insight, scientific rigor, and regulatory excellence to programs.