Regulatory Affairs

Our Services

Generics, Biosimilars & Combination Products

Accelerating Market Entry Through Scientific and Regulatory Excellence Overview The development and approval of generics, biosimilars, and drug–device combination products require a precise balance between regulatory compliance, scientific justification, and…

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CMC & Quality (Drug Substance & Drug Product)

Delivering Manufacturing Excellence and Regulatory Confidence Overview Quality and consistency are the foundation of every successful regulatory submission.At North Pharma Consulting, we provide expert support in Chemistry, Manufacturing and Controls…

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Lifecycle Management (Post-Approval)

Ensuring Long-Term Compliance and Product Sustainability Overview After a product is approved, the regulatory journey doesn’t end — it evolves.At North Pharma Consulting, we provide comprehensive post-approval support to help…

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Scientific Advice & Agency Interaction

Empowering Regulatory Success Through Early Dialogue with Authorities Overview Early and well-prepared engagement with regulatory authorities is critical for a successful product development and market approval strategy.At North Pharma Consulting,…

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Product Registration & Licensing Assistance

From Development to Market – Guiding Every Step Toward Approval Overview At North Pharma Consulting, we support pharmaceutical and biotech companies throughout the entire product registration lifecycle — from the…

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Regulatory Affairs Submission Management

Streamlined Coordination for Efficient Market Approvals Overview At North Pharma Consulting, we provide end-to-end management of regulatory submissions — from dossier authoring to agency communication — ensuring that your product…

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Regulatory Strategy & Intelligence

Building Smart Pathways to Global Market Access Overview In an increasingly complex regulatory landscape, a well-defined strategy is key to bringing your product to market efficiently and sustainably.North Pharma Consulting…

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How We Work

Efficient Support
in Four Clear Steps

Understanding Your Goals

We begin with a detailed discussion to assess your product, target markets, and regulatory priorities.

Strategic Planning

Our experts design a tailored regulatory and market access roadmap to ensure full compliance and efficiency.

Implementation & Coordination

We manage the submission process, communication with authorities, and coordination with local partners.

Market Entry & Ongoing Support

After approval, we continue supporting lifecycle management, updates, and post-approval activities.

What We Do

Our Core Values Guide Everything We Do

We help pharmaceutical and healthcare companies navigate complex global regulations and bring products to market efficiently and compliantly.

Our Regulatory Consultancy team develops tailored strategies to streamline approvals, ensure compliance with regional requirements, and accelerate patient access to innovative therapies.

Through close collaboration with authorities and market experts, we support every stage — from dossier preparation to post-approval maintenance — ensuring your products reach the right markets faster.

Effective regulatory consultancy ensures that products meet all regional standards, accelerating approvals while reducing compliance risks.
Our experts transform complex requirements into clear, actionable pathways that help pharmaceutical companies enter markets faster and more confidently.

We tailor each strategy to your product and target region — combining scientific knowledge, regulatory experience, and market insights.
By working closely with health authorities and local partners, we ensure a seamless journey from submission to commercialization

Our integrated approach helps clients reduce time-to-market, maintain compliance excellence, and achieve long-term growth across multiple markets.
With North Pharma Consulting, you gain a trusted partner focused on your success and sustainable patient access worldwide.

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Let’s Work Together

Contact Us To Plan Your
Next Regulatory Project

Partner with us

We ensure reliable support and long-term collaboration for your business growth

Contact Us

Address

The Hague, Netherlands

Partner with us

We ensure reliable support and long-term collaboration for your business growth

Contact Us

Address

The Hague, Netherlands

Let’s Work Together

Contact Us To Plan Your
Next Regulatory Project