Effective
Commercialization
Tailored Regulatory CMC Services
Enabling Approvals and Commercialization
R3LS is your life sciences consulting partner, providing tailored CMC regulatory services to ensure the regulatory success of your products at all stages of drug development. The knowledgeable and experienced team of regulatory professionals at R3LS leverage decades of CMC global regulatory experience to provide your company with sound regulatory CMC guidance. Each of our partners has specific areas of expertise; as a team, we provide customized life sciences consulting for your pharmaceutical, biologic, and cell and gene therapy product.
Global Regulatory
CMC Services
Our services, which include strategic advice, submission preparation and authoring, staff augmentation and due diligence assessments, give you the best chances of gaining approval from regulatory agencies for clinical studies, drug manufacturing, or product marketing. Avoid setbacks by relying on our seasoned professionals for gap analysis, risk assessments for all drug development stages, health authority package authoring, and due diligence before asset purchases of all phases.
Strategy
We can help you identify and mitigate any gaps or risks in your global Regulatory CMC strategy and documentation through our expert gap analysis and risk assessments. Additionally, we develop regulatory CMC strategies for products in all stages of drug development: preclinical, clinical, commercialization and post-approval as well as advise clients on interactions with health authorities to achieve desired goals. Rely on our expertise to provide your company with productive health authority interactions and help you achieve regulatory success.
Authoring
and Submission Preparation
Our Submission Preparation and Authoring service includes authoring of Health Authority meeting packages and Module 2.3 and 3 authoring for small molecule, biologics and cell and gene therapies. This includes the preparation of EMEA scientific advice; FDA meeting requests; briefing packages, clinical trial applications (IND/IMPD/CTA), marketing applications (BLA, NDA, MAA, ANDA, 505(b)(2)) and post-approval submissions as well as lifecycle management activities. With our expertise in life sciences consulting and regulatory CMC services, R3LS can facilitate or lead the successful preparation of these applications for submission.
Staff
Augmentation
Our experienced Regulatory CMC professionals are available for short or long-term roles in companies that lack dedicated FTEs and require project-based assistance or interim coverage during periods of growth or attrition. We provide interim and long-term leadership assignments, department and personnel management, departmental design, project-based staffing and leadership.
Due
Diligence
Our Due Diligence Gap and Risk assessments identify potential manufacturing, analytical and quality risks associated with investing or in-licensing in assets across all phases of small molecules, biologics, cell and gene therapies. R3LS’s experts have extensive experience analyzing CMC documentation such as drug substance and product development reports, regulatory submission packages, agency correspondence, and development plans for clinical and commercial supply. By leveraging this experience, R3LS ensures that our clients have the necessary CMC preparedness to meet their business objectives.
Global Regulatory CMC Phases
Pre-Ind & Ind / CTA
Phase I
Phase II
Phase III
Commercialization / Post Approval
Why Choose R3LS for Expert Regulatory CMC Consulting
Your Bridge To The Market
Global Regulatory Expertise
Our experienced, reliable, efficient and knowledgeable team of regulatory professionals understands the processes to achieve regulatory submissions and approvals, allowing you to save time and effort in getting your product to market.
Global Regulatory Experience
R3LS' team has extensive global experience and understands the technical, scientific and pragmatic aspects of life sciences consulting. Our CMC expertise, persuasive negotiatiing skills and knowledge of health authority requirements equals a comprehensive approach to Regulatory CMC challenges.
Accessible Team of Regulatory Professionals
Regardless of the scale of your project, you’ll have direct access to R3LS’ Partners, each with a specific area of scientific and regulatory CMC expertise. Our Partners work as a team, leveraging decades of complementary skills and experiences, to offer you customized advice and services to meet your individual needs.
Personalized Service
Our life sciences consulting experts take a proactive approach to understanding and responding to our clients' individual needs. Our CMC regulatory services are tailored to the precise specifications of each customer, allowing us to develop a comprehensive solution that is perfect for them. We collaborate closely with our clients, providing a personalized experience that exceeds expectations.
Exceeding Expectations: A Client's Perspective
My firm used R3LS to fill a significant gap in our Regulatory CMC team resourcing and I was immediately impressed by the R3LS team’s insight and expertise. They integrated seamlessly into our project teams and were a pleasure to work with. We relied heavily on their strategic insights as well as their execution capabilities and they did not disappoint.
~ VP, Regulatory CMC
My firm needed a Regulatory CMC resource to help prepare the technical section of an IND for a CAR T. R3LS provided the input and leadership to produce the CMC section that was accepted by the FDA with minimal follow-up questions. The internal team was very satisfied with their work and collaboration, and as a result, we hired R3LS again to help prepare another IND for a different product. I would highly recommend them.
~ Chief Regulatory Officer
Achieve Pre-Clinical to Commercialization Success Today with Life Sciences Consulting
Obtaining approval of clinical and commercial applications can be a daunting process.
That’s why you need a team of seasoned regulatory professionals with a substantial history of successful clinical and commercial application approvals in pharmaceutical, biologic, and cell and gene therapy product development, from pre-clinical to commercialization. With our expertise and guidance, you can achieve regulatory success for your business and make a difference in patients' lives.
Get Started Today!
Contact us now to learn more about how we can support a successful market launch for your product!
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