Navigating Business Challenges with Confidence
Experienced regulatory professionals ready to support your Global CMC content filing needs, with specialized small molecule and biologic product expertise. Proven track record in effectively managing the complex regulatory processes involved in bringing pharmaceutical products to market.
From early stage pre-clinical through registration product development, we can guide your organization to develop a compliant, phased-appropriate process control strategy. With a focus on collaboration with CMC experts, we deliver technical content that aligns with the specific requirements and guidelines of regulatory authorities worldwide.
Our team comprises of highly skilled regulatory CMC consultants with extensive experience in manufacturing product development from start ups to large pharma. We can support deliverables from major milestone submissions, Health Authority interactions, to day to day GMP regulatory compliance activities. We are here to progress your company goals with ease and confidence.
About Regulatory CMC Solutions LLC
Our Vision
At Regulatory CMC Solutions, LLC, our vision is to set the industry standard by delivering expert Regulatory CMC consulting services. We aspire to be your trusted partner, providing invaluable strategic guidance, unmatched technical writing excellence, and dependable support throughout your entire product development lifecycle. Our unwavering commitment is to continually exceed client expectations, becoming an indispensable and trusted asset within your team.
About Regulatory CMC Solutions LLC
Our Approach
We take a data-driven approach to consulting, where we integrate effective strategies into product lifecycle planning and execution, while maximizing efficiencies in submission deliverables. Our approach is highly customizable to meet the unique needs of each client.
About Regulatory CMC Solutions LLC
Our Team
Carly Evans, Founder
Principal Regulatory Consultant
Carly is a seasoned regulatory Chemistry, Manufacturing, and Controls (CMC) strategist with extensive experience across various therapeutic modalities, including small molecules and biologics. Over 20-year tenure in the regulatory CMC function, she has successfully led CMC teams through the entire product development life cycle, starting from initial Investigational New Drug (IND)/Clinical Trial Application (CTA) submissions to global marketing application development and post-approval maintenance.
Carly's diverse background has provided her with direct experience in handling breakthrough product applications with demanding timelines. She has a track record of frequent interactions with regulatory agencies to implement emerging technologies for new product development. Her expertise extends to managing large volume products, emphasizing the importance of collaboration with quality assurance, manufacturing operations, and supply chain planning. This collaboration ensures the selection of appropriate scales and proactive change management for post-approval modifications, ultimately maintaining market supply and preventing drug shortages.
As a critical and analytical thinker, Carly is dedicated to maximizing efficiencies in product lifecycle management. She has demonstrated her ability to build a culture of trust within cross-functional teams, fostering collaboration to meet the strategic objectives of the business. Carly's skills encompass strategic planning, regulatory compliance, and effective communication, making her an invaluable asset in navigating the complexities of regulatory affairs in the pharmaceutical industry.
https://www.linkedin.com/in/carly-evans-9685667/
Contact carly@regcmcsolutions.com to schedule an Introduction Meeting to discuss your Regulatory CMC needs.
Brooke Ashleigh
Senior Regulatory Consultant
Brooke excels in innovative and collaborative environments where her approach and leadership style have consistently fostered team cohesion and success. She brings us 20 years of industry experience, encompassing small molecule pharmaceuticals, medical devices, and combination products. With a solid foundation in analytical laboratory roles, Brooke possesses comprehensive expertise in analytical development, cGMP release, stability, and manufacturing activities. As a RAC-US credentialed regulatory CMC professional, Brooke has demonstrated proficiency in leading cross-functional teams through regulatory strategies, submissions, and interactions with health authorities worldwide, from first in human (FIH) through marketing applications.
Brooke is recognized by collaborators as the glue that holds teams together. She works tirelessly to implement solutions and transform vision into reality, and as a lifelong learner, she actively absorbs and analyzes information to stay at the forefront of industry advancements and innovative strategies. Brooke’s proactive commitment to continuous improvement and a results-driven mindset distinguish her as a dynamic force in the regulatory CMC field. With Brooke on your team, her dedicated approach to reducing redundancy while driving change will seamlessly move your projects forward.
https://www.linkedin.com/in/brookeashleigh/
Molly Zapp
Senior Regulatory Consultant
Molly has served as Regulatory CMC Strategic Lead for multiple BLAs and MAAs for monoclonal antibody products across diverse therapeutic areas, including immunology and inflammation, oncology, rare disease, and infectious disease.
Molly has developed strategy and authored documentation supporting critical health authority interactions, including pre-BLA meetings and agency Q&A responses for Breakthrough Designated therapies. She has led Regulatory CMC authoring and strategy for the global rollout of initial marketing applications across the EU, Japan, Canada, Asia-Pacific, and Latin America, developing submission plans to support the lifecycle maintenance of marketing applications, including change control assessments, submission timelines and strategies, and authoring major post-approval submissions encompassing site transfers, process scale-ups, formulation changes, and the introduction of combination products such as autoinjectors and prefilled syringes.
She is recognized for her collaborative approach, attention to detail, and ability to work effectively across cross-functional teams to support high-quality regulatory submissions and the successful execution of complex development programs. Molly has a proven track record of leading cross-functional collaboration across technical, quality, manufacturing, and regulatory disciplines, aligning stakeholders to drive efficient program execution and high-quality deliverables.