The Regulatory Stone

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A REGULATORY ADVISOR IN THE NETHERLANDS AND ITALY

PROFESSIONAL PHARMACEUTICAL ADVICE

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Our Services

Patient at the Center

We prioritize patients' well-being in all our regulatory efforts.

Quality Customer Service

We provide responsive, tailored solutions for your needs.

Long-Term Profitability

We secure sustainable regulatory success for your lasting profitability.

ABOUT US

Our Elevation Pitch

We are a company that provides advice on regulatory matters to pharmaceutical companies to ensure a safe, continuous supply of medicinal products to patients and a sustainable, profitable regulatory position with health authorities in the Netherlands, Italy and Europe.

Oral Dosage

Our expertise in oral dosage forms covers a broad spectrum of pharmaceutical products, including tablets, capsules, powders, and suspensions.

Parenteral Dosage

Our specialization in parenteral dosage forms encompasses intravenous (IV) and subcutaneous (SC) injectables.

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Our services

Core Services

All Services
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Chemistry Manufacturing and Controls (CMC)

Our CMC services oversee the end-to-end management of pharmaceutical product development, ensuring quality, safety, and efficacy from formulation to production and regulatory compliance.

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Paediatric Investigation Plan (PIP) Submissions

We specialize in crafting and submitting PIPs, designed to facilitate the development of medicinal products for pediatric use, navigating the complex regulatory requirements to ensure child-specific safety and efficacy.

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Identification of Medical Products (IDMP)

Our IDMP services involve precise identification, classification, and documentation of medicinal products, ensuring compliance with international standards and improving pharmacovigilance, regulatory reporting, and product information management.

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CEP/CoS

We can support you in the addition, maintenance or deletion of your certificate of suitability to the European Pharmacopoeia (CEP/CoS). Our consultant is experienced in various CEP submission including major and minor changes.

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Regulatory Intelligence

We offer comprehensive regulatory intelligence services, providing pharmaceutical companies with strategic insights, trends, and updates on evolving regulatory guidelines, allowing for informed decision-making and compliance with changing industry standards.

Additional Services

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Professional Scientific Consultation

In the pursuit of marketing authorization, clients often seek expert guidance on intricate scientific issues. Our consultancy services extend to aiding you in the formulation of comprehensive briefing documents and supporting materials for soliciting scientific advice from esteemed regulatory bodies such as the European Medicines Agency (EMA) or the Dutch Medicines Evaluation Board (CBG/MEB).

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Document Translation and Legalization

Our proficiency encompasses the translation and legalization of critical documents, including but not limited to labels, facilitating seamless communication between English and Dutch. Trust us to ensure precision and compliance in this vital aspect of your regulatory requirements.

Our Distinctive Edge

What Makes Us Different

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.

Consult Us Today!

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