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Article 61(10) of MDR: A Pathway for Medical Device Software?
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The Compliance Compass: Guiding Clinical Investigations for Medical Devices through ISO 14155 and MDR
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Dutch Life Sciences & Health Mission to Japan
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We Are Excited to Attend BioTechX 2024 in Basel!
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EMA Pilot Program for Orphan Medical Devices
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Biological Evaluation of Medical Devices from a Risk Management Perspective: Key Steps and Common Pitfalls
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Starodub Whitepapers

MEB Planning Tool Mandatory from 1 July 2025

ICH Q1A Guideline – Stability Testing of Drug Substances and Products – open for consultation

Meet Starodub at HollandBIO Dutch Biotech Event – 27 June 2025

We’re excited to be part of the upcoming Life Sciences & Health Mission to Japan!

🚀 Powering Biotech Forward: Liberi Group & Starodub Join Forces 🤝

Expanding Our Expertise: Regulatory Affairs & Quality, Compliance & Improvements

New White Paper: The Challenges of Using nIVD MA ToC for Medical Device Registration

Boost Your Clinical & Regulatory Success in EU – Join Our Free Webinar!

Harnessing AI at regulators: How the FDA and EMA are innovating AI use

How Early Regulatory Input Strengthens CDMO Selection and Project Success

Key Takeaways from the Palleos Webinar on EU Clinical Trials

From Bench to Bedside: Nonclinical data requirements to initiate first-in-human studies of ATMPs

BIO KOREA 2025 – Building a Healthier World Together

Easter Lunch

✈️Boost Your Clinical & Regulatory Success in EU – Join Our Free Webinar! 

World Health Day and World Parkinson’s Day

Navigating the Evolving Regulatory Landscape of ATMPs and Medical Devices

New on Our Website: Smart Navigation & Support!

EMA Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms

No ASMF Procedure for Biological Drug Substances? Here’s What You Need to Know

Human Medicines in 2024 (overview)

FDA Updated Guidance on Nitrosamine Impurities

Regulatory challenges in the classification of drug-device combinations

One standardized icon set for clearer medication information

EMA Updates Post-Approval Application Guidance Effective 1 January 2025

Updates on eCTD Submissions for the EU: Are You Ready?

How ready are you for MDR submission?

Regulatory Affairs: A Marathon of Dedication and Strategy

Looking Back on Milestones and Forward to the Future

Interpretation of Well-Established Technology (WET) under the EU MDR

Medical Devices with Coatings: Impact on Classification

From Formatting to Submission: End-to-End eCTD Support

AI in Medical Devices: Key Highlights of the New Team NB Position Paper

Public consultations on package insert and labelling policy

Starodub is attending Medica 2024

Exciting News from Starodub!

International Side Effects Week: How you can (sometimes) prevent side effects yourself

Comprehensive MDR Compliance: Key Recommendations for Medical Device Manufacturers

Is Your Post-Market Surveillance (PMS) System Fully MDR-Compliant? 

Regulatory Affairs, Drug Development & AI: Navigating the New EMA Guidance

Change in distribution Direct Healthcare Professional Communication in the Netherlands

Key Outcomes of LSH Dutch Mission to Japan: New Partnerships to Support Market Entry

Vigilance and Incident Reporting of Medical Devices per MDR 2017/745 

Starodub’s eCTD team present at eCTD v4.0 Masterclasses

Product for Diagnostic Purposes: Medical Device or Medicinal Product

Impact of the new EU Artificial Intelligence Act on medical devices

New revision of Guideline on Environmental Risk Assessments by EMA

Windsor Framework – Changes to the licensing of medicines for human use in the UK (and affecting Northern Ireland)

Unlocking Innovation with EMA’s Innovation Task Force

The International Recognition Procedure (IRP) for Medicinal Products in the UK

Understanding the Differences Between Medical Devices with Ancillary Substances and Substance-Based Medical Devices

Seamless Transition to eCTD in Ukraine: Discover Our Services

Sharing the power of teamwork!

Revised ICH guideline Q2(R1) on Validation of Analytical Procedures

When to Submit a New 510(k) for Medical Device Changes?

Zero Day MR Procedure

New ICH guideline Q14 on Analytical Procedure Development

Regulatory Affairs is like searching for Easter eggs!

Little knowledge about the influence of herbal remedies on medicines

Top 10 Deficiencies in New Applications for a Certificate of Suitability (CEP)

Regulatory Procedure Management for Centrally Authorised Products transitions to IRIS platform

Goodbye

Are 6-month chronic toxicity studies always necessary for nonclinical safety assessment of therapeutic monoclonal antibodies?

Dutch Agency MEB expands options for Planning Tool for requesting time slots

Unlocking Potential: The Vital Role of GSPR in Medical Device Development

Regulation on Health Technology Assessment (HTA)

Clinical evaluation strategy for Medical Device Software certification under MDR/IVDR

Outscoring your regulatory affairs activities? Why?

STARoDub Outing 2023

Toxicological risk assessment of mutagenic impurities

Is it possible to optimize development process of your medicinal product?

STARoDub @ BioEurope Munchen and Nordic Life Science (NLS) Days in Copenhagen

Draft guideline on the Development and Manufacture of Synthetic Peptides

Navigating EU Regulatory Compliance for Medical Devices with Ancillary Medicinal Substances

Meet our eCTD team

Meet us at Bio-Europe 2023 in Munich and/or at NLS Days 2023 in Copenhagen

Turkish lunch

Meet STARoDub’s Medical device team

EMA and FDA: Collaborative Parallel Scientific Advice

Milestone – 20 years of regulatory collaboration EMA and FDA

Antimicrobial Resistance (AMR): Leveraging Biotech for a Solution

Nitrosamines

EMA Draft Paper: AI for Safer Medicine

Product Development Checklist

Electronic Product Information (ePI)

Importance of Regulatory Intelligence and Staying Up to Date

World Hepatitis Day

The impact of Quality Target Product Profile

Rare Pediatric Disease Designation (RPDD)

Value of Real World Evidence (RWE) in regulatory decision making process

STARoDub @ HollandBIO’s Dutch Biotech Event

Meet STARoDub’s small molecules team

World Blood Donor Day

Risk Management of Medical Devices

Antisense oligonucleotides (ASOs) in drug development

HIV vaccine awareness day

Impact of Big Data on medicine regulatory network

Meet the Starodub’s nonclinical team

World Immunization Week

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