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Regulatory Affairs

Navigating the complexities of regulatory requirements is crucial for successful drug development. We offer comprehensive regulatory support leveraging extensive industry experience (over 150 years in total) and a proven track record.

PIP & iPSP ›

Meeting the regulatory requirements for medicines intended for children involves careful planning and compliance with Pediatric Study Plans (PIP) in Europe and Pediatric Investigation Plans (iPSP) in the United States. These plans are critical for ensuring that medications are safe and effective for pediatric use.

Regulatory Support for Small Molecules ›

Ensuring compliance with regulatory standards is imperative for the success and safety of small molecule products, whether originals or generics.

Designation support ›

We guide pharmaceutical and biotechnology companies through the complex regulatory landscape. Our expert team is dedicated to helping you achieve specific regulatory designations such as PRIME, Breakthrough Therapy, Fast Track, RMAT, Priority Review, and CAT, ensuring your innovative therapies reach patients swiftly and efficiently

Support for biologicals ›

Navigating the regulatory landscape is crucial for ensuring the safety and success of your biological and biotech products. In an environment characterized by rapid innovation and complex science, strict adherence to regulatory standards is essential to ensure your products are safe, effective, and accessible to the market.

Small & Medium Enterprise ›

By partnering with us, you can make the most of our SME qualification to enhance your regulatory strategy and reduce costs indirectly through strategic planning and access to available incentives.

CTD Module 1 support ›

Specializing in CTD (Common Technical Document) Module 1 support, we offer comprehensive services designed to streamline your submission process and ensure compliance with regulatory requirements.

RA support (interim, temporary, long lasting) ›

We understand the complexities and challenges of navigating regulatory requirements in the pharmaceutical and biotechnology industries. Whether you need interim, temporary, or long-lasting regulatory affairs support, our team of experts is here to ensure your projects stay on track and compliant with all regulations.

Life Cycle Management ›

Successfully navigating the post-approval phase of your product’s life cycle is critical for maintaining market presence and ensuring continued compliance. Our comprehensive regulatory affairs services for post-approval life-cycle management are designed to support you in every step of the way, from ongoing compliance to strategic updates and optimizations.

Orphan Drug Designation Support ›

Navigating the path to orphan drug designation can be complex, but our regulatory affairs consultancy is here to guide you every step of the way. We specialize in securing orphan drug status for your products, ensuring you benefit from the incentives and market exclusivity this designation provides.

Agency Interactions ›

Navigating the regulatory landscape is crucial to the successful development and commercialization of pharmaceuticals and biopharmaceuticals.

Regulatory Guidance Check ›

Maintaining compliance with evolving regulatory standards is critical for preserving market access and ensuring product integrity. Our regulatory guidance check services are tailored to safeguard your existing marketing authorizations, Active Substance Master Files (ASMF), Drug Master Files (DMF) or manufacturing processes and analytical methods.

Comprehensive Regulatory Support from Development to Market

Navigating the complexities of regulatory requirements is crucial for successful drug development. We offer comprehensive regulatory support leveraging extensive industry experience (over 150 years in total) and a proven track record. Our experts guide you through all steps necessary to complete the regulatory actions necessary from early development, obtaining marketing authorization and post approval activities.

What can we do for you?

Since its inception, Starodub has provided regulatory consultancy for more than 160 projects, thereby accumulating substantial experience and expertise to guide you comprehensively through every stage of the regulatory process.

Our collaborative approach ensures seamless integration with other disciplines, including non-clinical, clinical, and CMC. This comprehensive support guarantees that your regulatory aspects are fully aligned with overall development and regulatory strategies.

Engaging with us can help your regulatory submissions and accelerate your journey from development to market. Our goal is to ensure your products reach patients safely and efficiently.

Partner with us to navigate the complexities of (bio)pharmaceutical regulation with confidence. Contact us today to learn how we can support your development and regulatory needs.

Femke Jacobs
Senior RA Manager

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We collaborate with clients and care about their patients' needs

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Approach & Expertise

Learn how we can support you in meeting your business goals

  • Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
  • Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
  • At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
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Our Office
Industriestraat 14
5391 BR Nuland
The Netherlands
Email
[email protected]
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Starodub – a team of experts in regulatory affairs

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Femke Jacobs
Senior RA Manager

Let's Connect

Talk to an expert