Crossroads Regulatory Consulting

Boutique Regulatory Consulting Firm

At Crossroads Regulatory Consulting, we understand the complexities and challenges that come with product development within the constantly evolving biopharmaceutical industry. That’s why we’re here to offer our unwavering support, guidance, and expertise every step of the way and along every phase of development.

Regulatory Affairs

  • Regulatory Strategy
  • Regulatory CMC
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Technical CMC

  • Development
  • Commercial
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What We Offer

Strategic Expertise

Strategic advisors that execute on the detail – what you see is what you get

Customized Strategies

Trusted partners that provide customized regulatory strategies to meet client’s unique needs

Life Cycle Support

Distinct yet synergistic regulatory expertise to support the life cycle of your product(s)

End to End

One stop shop for regulatory CMC and technical oversight of your product development

Why Choose Us

CRC stands out as a boutique firm, designed for scalability to accommodate client requirements. Yet, amidst our adaptability, we remain unwavering in our promise to be your exclusive point of contact—a dedicated partner committed to navigating the regulatory landscape with you. 

IND/IMPD/CTA

Global HA Interactions

Marketing Applications

Clients Served

Years of Experience

Designation Applications

Expertise

Our team consists of experienced professionals with in-depth knowledge of the pharmaceutical industry, regulatory requirements, and market dynamics.

Tailored Solutions

We understand that each drug development journey is unique. That’s why we provide customized solutions that address your specific needs and challenges, no matter what phase of development you are in.

Partnership Approach

We believe in building long-term partnerships with our clients, and this client-centric approach means we place your needs and goals at the forefront of our services.

Results-Oriented

Our focus is on helping you achieve tangible results. We are committed to your success and the successful commercialization of your pharmaceutical drug.

Regulatory Strategy

Full lifecycle regulatory development and planning

Regulatory submissions and project management oversight

Health Authority interaction strategy and execution

Regulatory strategy document preparation

Target label profile development

Company core data sheet and region- specific label strategy and creation

Regulatory intelligence

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We are committed to delivering tailored solutions, staying ahead of regulatory changes, and sharing knowledge to enable our clients to make informed decisions leading to patient access.

about us

Regulatory CMC

Author CMC regulatory eCTD global submissions for development and life cycle programs

CMC submissions and project management oversight

Health Authority CMC interaction, strategy, and execution

CMC regulatory intelligence

Guidance on development, manufacturing, process, and commercial challenges regarding regulatory CMC

Technical CMC report drafting

Collaboration and integration with technical CMC functions for science-based decisions

Technical CMC

Development

Route/formulation evaluation and guidance with external manufacturing vendors

Identification and determination of fit for contract manufacturing sites

Contract site management for development of DS and DP

Couple technical development with regulatory CMC strategy

Technical CMC

Commercial

Commercial launch readiness

Technical transfer and validation oversight for new sites

Due diligence and guidance on contract manufacturer selection for DS and DP

Integration of technical CMC, supply chain, and regulatory CMC

Angela Neufeld

Co-Founder & Principal Strategy Consultant

Strategically focused Regulatory Affairs professional with 19 years of broad drug development experience from pre-IND through post-marketing. Extensive expertise in regulatory strategic planning and global regulatory requirements & guidelines. Successful history of preparing and submitting regulatory submissions. Expertise in NDA preparation and execution. Skilled at preparing and leading teams through successful global Health Authority interactions. Exceptional problem-solving abilities and analytical skills to navigate complex regulatory landscapes.

Our Story

In 2021, our journey began, and as years of collaboration unfolded, it became evident that our shared work ethic and drive, coupled with diverse experiences, laid the foundation for our partnership. From this shared vision emerged CRC, a distinctive regulatory consulting firm crafted to offer personalized solutions. Our backgrounds intertwine seamlessly to form a unique tapestry of expertise, allowing us to deliver tailored strategies that meet the diverse needs of our clients. With a cumulative industry experience of 40 years, our team brings a wealth of insights gained across biotech startups and multinational pharmaceutical corporations alike. 

why choose us

Sam Salamone

Co-Founder & Principal CMC Consultant

Strategically focused regulatory and technical professional with 20+ years of broad drug development experience from Pre-IND to post-marketing. Extensive expertise and implementation in CMC strategy and global regulatory requirements & guidelines. Successful history of guiding CMC regulatory and technical development for virtual based organizations to multi-national companies. Expertise in clinical phase through marketing application preparation and execution, including Health Authority meetings and interactions for CMC.

 

"Crossroads Regulatory Consulting has made a tremendous impact on our late stage programs. Their experience helped craft nimble strategies and impactful tactics that drove speed and rigor into our programs. Most importantly, Crossroads Regulatory Consulting worked with a level of commitment and dedication to our programs that I have not experienced with other firms. Their interest and focus far exceeds the transactional execution of a contract, more representing professionals driven by bringing important medicines to address serious need."

"Crossroads Regulatory has established itself as a reliable and enduring partner for our business. They consistently achieve positive outcomes across diverse programs through their expertise in regulatory and technical strategy and implementation. Their dedication to delivering timely, scientifically grounded strategies, coupled with their hands-on approach, greatly contributes to our business's success."

"I have worked with many regulatory strategists in my 25+ years in biopharma. Very few have risen to the level of competence and focus on the critical issues that Angela does. If you want a team that is practical in their approach and highly skilled, I could not recommend this team more."

"Angela is hard working, strategic, and collaborative; working with her was great, even when projects were difficult and resources scarce. I would recommend working with her at any company. She is able to provide expertise while being on top of new developments in the regulatory environment. You can count on her to deliver quality work and on time."

“Sam seamlessly integrated into our TechOps team, providing valuable regulatory-CMC strategic guidance blended with technical expertise that has been central to program progress. His expertise and collaborative communication style enabled him to immediately make an impact. With Sam’s significant experience across development stages, he will no doubt be a critical team member for late-stage and NDA preparations to ensure a successful filing.”