The Regulatory Stone

About Us

A REGULATORY ADVISOR IN THE NETHERLANDS AND ITALY
welcome to our pharmaceutical consulting center

The Regulatory Stone

We are a regulatory consulting firm, dedicated to supporting pharmaceutical companies in navigating the complex regulatory landscape. Our mission is to ensure a secure and uninterrupted supply of medicinal products to patients while establishing a sustainable and profitable regulatory position with health authorities in both the Netherlands, Italy and Europe. With a focus on oral dosage forms, we bring extensive expertise in the development and regulatory compliance of a wide range of pharmaceutical products, including tablets, capsules, powders, and suspensions. Additionally, our specialization extends to parenteral dosage forms, covering intravenous (IV) and subcutaneous (SC) injectables. Trust us to provide tailored advice and guidance, helping your company achieve regulatory success and contribute to the well-being of patients.

Patient Experience
Quality Customer Service
Long-Term Profitability
WHY CHOOSE US

We Always Ready For A Challenge.

Our consultant has worked with 4 of the top 20 global pharma companies, ensuring your projects benefit from industry-leading expertise.

With onsite support throughout the Netherlands, we provide localized guidance with a global perspective.

Our specialization in Dutch and European Health Authorities ensures precision in navigating complex regulatory landscapes.

Niche Areas
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Global Pharmas xp
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YEARS OF EXPERIENCE
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EXPERIENCED PERSONNEL

MEET YOUR CONSULTANT

Adebowale Adekunbi

Consultant

Adebowale is a distinguished pharmaceutical and regulatory affairs expert with a strong academic foundation and extensive industry expertise. Graduating summa cum laude with an MSc in Pharma in 2013, he further specialized in Pharmaceuticals Technology and Regulatory Affairs, earning his second MSc in 2016. His commitment to advancing healthcare led him to achieve a Postgraduate Diploma in Medical Devices and Cosmetics Regulatory Affairs in 2022. Most recently, he became RAC Certified in 2024, reflecting his dedication to maintaining the highest standards in regulatory compliance and innovation within the pharmaceutical and medical device sectors.

general questions

Frequently Asked Questions

Our CMC services cover the entire spectrum of pharmaceutical product development. From formulation to production and regulatory compliance, we ensure the highest standards of quality, safety, and efficacy. Our end-to-end management approach guarantees a seamless process, meeting the complex demands of pharmaceutical development.

What distinguishes us is our unparalleled expertise and extensive industry connections. Our consultant has successfully collaborated with four of the top 20 global pharmaceutical companies, bringing invaluable insights and best practices to your projects. With a local presence offering onsite support throughout the Netherlands, we provide guidance with a global perspective. Moreover, our specialization in Dutch and European Health Authorities makes us regulatory experts, ensuring precision in navigating complex regulatory landscapes at both local and European levels.

Staying compliant with ever-changing healthcare regulations is crucial. Our consultants are well-versed in the latest industry standards and compliance requirements. We conduct thorough assessments of your practice, identify potential areas of non-compliance, and provide guidance on implementing policies and procedures to meet regulatory standards, reducing the risk of penalties and legal issues.

Our commitment to staying at the forefront of industry trends allows us to provide you with comprehensive regulatory intelligence services. We offer strategic insights, regular updates on evolving guidelines, and trends shaping the healthcare landscape. This ensures that your practice remains well-informed, agile, and positioned to make informed decisions, staying ahead of the curve in a rapidly evolving healthcare environment.

Absolutely. Our consulting services are adaptable to practices of varying sizes and specialties. Whether you’re a small independent practice or a larger healthcare organization, our consultants have the expertise to address your specific needs. We tailor our approach to align with the unique dynamics and goals of your practice, ensuring that our services are both effective and scalable.

Initiating a partnership with us is simple. Book an appointment and we will reach out to you as soon as possible. During this meeting, we’ll discuss your practice’s needs, challenges, and goals. From there, we work collaboratively to implement solutions and support the ongoing success of your healthcare practice.

READY TO WORK WITH US?

Consult Us Today

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