About Us - CERES Regulatory
About Us
Innovative Strategic Regulatory Services Designed to Achieve First Cycle Approvals & Rescue from Regulatory Challenges
Welcome to CERES Regulatory Services, an international experiential regulatory consultancy for the medical foods, drugs, biologics, cell therapy, gene therapy, combination products, antibody drug conjugates, radiopharmaceuticals, advanced tissue products, and medical devices. We specialize in regulatory affairs services, regulatory strategy, regulatory intelligence and regulatory rescue. We offer “fractional” regulatory services guaranteeing expert guidance, experiential advice and personalized regulatory solutions that achieve first cycle review, approvals, and clearances.
Vison & Values
Regulatory Pioneers, Regulatory Pathway Innovators
We are committed to assisting our clients in developing revolutionary medical products and therapeutics to combat a wide range of indications affecting the human condition. Our number one priority is the patients that require the treatment our clients develop and deliver; they deserve the utmost quality as well as an increase in their quality of life. We depend on the drive and determination of our employees to achieve these goals and the Health Regulatory Agencies we interact and negotiate with. We perform our duties with constant concern and respect for the environment, community, clients, and regulators we serve.
Regulatory Mastery, Innovate Regulatory Pathway Development.
Discreet by Design
We blend innovation and precision to navigate regulatory intricacies seamlessly, ensuring excellence with a subtle touch that speaks volumes about your distinctive vision.
Distributed by Design
Innovating regulatory solutions seamlessly, our approach is intricately designed to ensure excellence, reflecting a commitment to distributing success across every aspect of your regulatory needs.
Vast Experiential Network
Navigating regulatory landscapes with precision and expertise, our expansive network ensures excellence in compliance and strategic solutions for your success.
FAQ’s
Frequently Asked Question?
At CERES Regulatory, our distinctiveness lies in our international expertise and focus on biotechnology, pharmaceutical advanced therapy medicinal products, and medical devices. Our specialization in regulatory affairs, strategy, intelligence, and rescue sets us apart, ensuring expert guidance and personalized solutions for seamless approvals.
Our “fractional” regulatory services provide clients with a unique advantage by offering tailored, flexible solutions. This approach guarantees expert advice, personalized strategies, and ensures a smooth regulatory process. Clients benefit from cost-effective, on-demand access to regulatory expertise, minimizing risks and maximizing efficiency.
CERES Regulatory is committed to achieving first cycle success through experiential advice and meticulous regulatory planning. Our team’s in-depth understanding of global regulatory landscapes ensures that your submissions are comprehensive, meeting the necessary requirements for swift reviews, approvals, and clearances.
Absolutely. CERES Regulatory specializes in regulatory rescue, helping clients navigate complex regulatory challenges. Our seasoned professionals bring extensive experience to identify and address issues promptly, ensuring a streamlined regulatory process and minimizing delays.
Regulatory intelligence is a cornerstone of our services. CERES Regulatory stays ahead of evolving regulations, providing clients with up-to-date insights. This proactive approach enables us to anticipate changes, adapt strategies accordingly, and ensure compliance, fostering a more resilient and future-proof regulatory pathway.
Our experiential advice stems from hands-on industry knowledge. Clients gain valuable insights from our team, which comprises experts with diverse regulatory experiences. This practical approach enhances decision-making, mitigates risks, and facilitates a smoother regulatory journey.
No, CERES Regulatory offers international expertise. Our consultants are well-versed in navigating regulatory landscapes globally. Whether your project spans multiple countries or focuses on a specific region, we provide comprehensive regulatory support tailored to meet diverse geographical requirements.
Engaging with CERES Regulatory is seamless. Reach out through our website or contact our team directly to discuss your regulatory requirements. We tailor our approach to your specific needs, ensuring a collaborative partnership geared towards achieving your regulatory milestones efficiently.
Meet Our Team!
Dr. Nigel A.S. Hernandez
Founder, Chief Clinical & Regulatory Science Officer
Engr. Asad Khan
Full Stack Developer
Shania T
Team Lead
Getting Started
To explore a partnership with us, please contact our business development team. We look forward to discussing your project and how our innovative approach to regulatory consulting can help accelerate your path to market, maximizing your company’s value and impact to patient care.
Book a 30 Minute Free Call.
A 30-minute meeting over the phone with a Senior U.S. Regulatory Consultant for Regulatory Services.
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Proactively deliver seamless core competencies with scalable. Completely fabricate transparent paradigms.
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