| arthurkamminga.nl | Kamminga Mobility & Legal | The website is currently under construction and encourages visitors to return for more content. The company's expertise includes business development, regulatory issues (specifically PSO Regulation 1370/2007 and Coach Regulation 1073/2009), and tender team support, utilizing creative network planning. Kamminga Mobility & Legal combines legal expertise with transportation market insights and planning skills, providing a unique advantage in tender bids and business opportunity identification. | Governance → Law 14133 | regulatory affairs 21 business development 121 planning 1969 | |
| raadvoorplantenrassen.nl | Plant Breeders Council | The Plant Breeders Council is responsible for granting plant breeder’s rights and authorizing plant varieties. Information is available on the website regarding online application submission, fees, submission and delivery requirements, and the procedure for maintaining a variety. The website also offers news, current topics (such as hemp and tulip registration), and publications such as the Council's 'Gazette'. | Government & Administration → Administrative Bodies 50 | authorization 32 regulation 1350 | Kaag en Braassem → Roelofarendsveen 348 |
| dada.nl | DADA Consultancy | The website provides an overview of DADA Consultancy’s services, including regulatory affairs, pharmaceutical development, pharmacovigilance, Pharmaceutical Safety and Efficacy, Market Access and Advertising Compliance, and QA Compliance. DADA Consultancy emphasizes customer focus, engagement of its employees, and meeting the needs of patients through its services. The company’s core business is providing tailored regulatory solutions, highlighting its role as an ideal partner for European regulatory activities. | | market access 11 regulatory affairs 21 compliance 506 | |
| lingeagroconsultancy.nl | Linge Agroconsultancy B.V. | The company provides a comprehensive service portfolio, including the preparation of dossiers and task forces, to assist clients with registering their products across various European countries. Linge Agroconsultancy has been operating since 2003 and collaborates with partners for trials and studies to ensure a streamlined registration process. The website outlines services such as active substance registration, IUCLID dossier preparation, and zonal/interzonal/national applications, catering to both government and industry clients. | Agriculture → Plant Protection 11 | dossier 248 application 3377 registration 4366 | |
| simon-consulting.nl | Simon Consulting | The website provides information about the consultancy's team, partners, and services, including advisory services, fintech licensing, and compliance audits. Several client testimonials highlight Simon Consulting's expertise in areas like financial crime compliance, regulatory development, and translating complex regulations into practical procedures. The consultancy emphasizes a collaborative approach, working with clients to understand their business needs and develop tailored solutions, as exemplified by their work on management information reports. | Financial Services → Compliance 399 | risk assessment 133 compliance 506 regulation 1350 consulting 3639 training 28133 | |
| starodub.nl | Starodub | Starodub consultants collaborate with (bio)pharmaceutical and medical device companies to guarantee regulatory compliance and support the realization of business goals. The firm offers services including due diligence, gap assessments, agency interaction, clinical evaluation, product qualification, and QMS consulting, covering areas like eCTD and DMS support. Founded in 2014, Starodub has grown to a team of approximately 20 employees and focuses on providing expertise particularly for Advanced Therapy Medicinal Products (ATMPs) in early development. | | regulatory affairs 21 medical device 57 | |
| dorian.nl | Dorian Regulatory Affairs B.V. | The company specializes in regulatory affairs and boasts extensive experience, particularly in biotechnology, oncology, dermatology, ophthalmoscopy, and gastrointestinal diseases. Founded in 1999 by Dorine Mulder, a biochemist and toxicologist with over 25 years of pharmaceutical registration experience, Dorian Regulatory Affairs initially focused on assisting clients outside of Europe. Dorian Regulatory Affairs maintains collaborations with local consultants for regulatory procedures in the US and Switzerland and has established professional contacts with national authorities and the EMA. | Health → Pharmaceuticals & Medical Products 2409 | regulatory affairs 21 biotechnology 27 consultancy 2596 registration 4366 | |
| simplexpharma.nl | Simplex pharma | The website is an initiative of Lidwine Boesten, an (industrial) pharmacist with over 25 years of experience in regulatory affairs, compliance, and pharmaceutical affairs. Simplex Pharma specializes in pharmaceutical advice and practical support in areas such as regulatory affairs, compliance, and pharmaceutical legislation. The company emphasizes a customer-focused and tailored approach to navigating the complex world of pharmaceutical rules and regulations. | Medical Care & Services → Pharmaceuticals & Pharmacy 453 | regulatory affairs 21 pharmaceutical 88 compliance 506 consultancy 2596 | |
| medicineshortagesdefects.nl | Ministry of Health, Welfare and Sport (VWS) | The centre facilitates submissions of notifications concerning initial market placement, revocation of existing supply problem notifications, modifications to existing notifications, discontinued marketing, reduced quantities, quality defects, and out-of-specification issues, particularly for advanced therapeutic medicinal products. Manufacturers, including compounding pharmacies, can utilize a dedicated notification form to report these concerns, with detailed procedures outlined in a user guide and frequently asked questions page. The notification centre is overseen by the Medicines Evaluation Board (MEB) and the Health and Youth Care Inspectorate (IGJ), commissioned by the Ministry of Health, Welfare and Sport (VWS). | Community → Government & Administration 10567 | authorization 32 notification 183 manufacturer 355 | |
| mdproject.nl | Medical Device Project B.V. | The company offers a range of services including training, clinical evaluation, biocompatibility evaluation, process validation, and risk management, tailored to manufacturers, suppliers, distributors, and users of medical devices. MDProject focuses on assisting clients with the design and development of medical devices, implementing Medical Device Regulations, and creating Technical Dossiers and Design History Files, aligning with standards like ISO 13485. They provide expert guidance on navigating regulatory requirements such as the EU MDR/IVDR and 21 CFR Part 820, with specific offerings for both non-active and active medical devices, including process validation, cleanroom environments, and clinical evaluation. | Pharmaceuticals & Medical Products → Medical Devices 388 | medical device 57 quality management 169 risk management 543 training 28133 | |
| ampharco.nl | AMPHARCO | Anthony, the owner of AMPHARCO, provides over 35 years of experience as an industrial pharmacist, offering expertise in various aspects of the pharmaceutical industry. The services offered include strategic advice, due diligence, tech transfer, quality management, auditing, and regulatory affairs management. The consultant provides both in-person consultations in an office setting and digital contact via various communication channels, such as Teams, Zoom, and Skype. | Medical Care & Services → Pharmaceuticals & Pharmacy 453 | regulatory affairs 21 pharmaceutical 88 consultancy 2596 production 4582 strategy 9379 | |
| biotopmedical.nl | BioTop Medical | The website details BioTop Medical’s services, including QMS implementation, auditing, risk management, clinical/performance evaluation, systematic literature searches, and biological evaluation. The company caters to businesses of various sizes – start-ups, medium-sized companies, and large established entities – offering tailored strategies for regulatory affairs and quality assurance. Established in 1997, BioTop Medical focuses on building long-term relationships with clients, fostering in-depth product and process knowledge to support successful market entry. | Pharmaceuticals & Medical Products → Medical Devices 388 | regulatory affairs 21 quality management system 28 risk management 543 | |
| platformbiociden.nl | Platform Biociden | Biocides are used to combat harmful organisms and are used for purposes such as disinfection and preservation. These products are applied by both individuals and professionals in various environments including households, businesses, and public spaces. The approval of biocides in the Netherlands is overseen by the College for the Authorization of Plant Protection Products and Biocides (Ctgb) after assessment of their efficacy and risks. | Environment → Food Safety 110 | biocide 10 authorization 32 risk 2896 | |
| pharmamax.nl | Pharma Max Consult BV (PMC) | The company offers interim on-site support during the development and marketing authorization process, as well as lifecycle management. PMC also provides tailored solutions and risk assessments to clients. Founded by Maxim Mikhalevitch, who possesses over 30 years of experience in the pharmaceutical industry, PMC collaborates with a network of regulatory affairs and GMP compliance consultancies. | Pharmaceuticals & Pharmacy → Pharmaceutical Services 99 | regulatory affairs 21 risk assessment 133 quality assurance 144 | |
| amstermed.nl | Amstermed | The website details Amstermed’s role as an Authorized Representative, acting as a legal entity and liaison between manufacturers and regulatory bodies across the European Union, United Kingdom, Australia, Switzerland, and the United States. Amstermed offers a range of services including documentation review, streamlined product registration, and legal representation, ensuring compliance with varying regulatory requirements in each region. The company's strategic global presence, bolstered by offices in key locations, aims to facilitate smooth market entry for manufacturers seeking to expand their reach within the medical device industry. | Pharmaceuticals & Medical Products → Medical Devices 388 | regulatory affairs 21 medical device 57 documentation 452 | |
| bretox.nl | Bretox | The website details Bretox's expertise in navigating the regulatory processes for biocides and plant protection products within the Netherlands, referencing the ‘overgangsrecht’ regulations. Bretox offers a range of services including feasibility studies, dossier preparation, and post-submission support, employing toxicologists and experts in environmental toxicity and risk assessment. Founded in 2014 by Christel Verberk, who possesses over 20 years of experience in regulatory consultancy and holds qualifications in environmental health sciences and toxicology. | Science → Environmental Science 180 | biocide 10 toxicology 12 dossier 248 registration 4366 | |
| komos.nl | KoMos | KoMos, short for Koos Oudshoorn Management Organisatie & Strategie, offers support with asset management challenges. KoMos’ approach focuses on connecting employees and identifying management, organization, and strategy elements to set goals and achieve results. KoMos can help organizations with quality improvement, project management, downtime reduction, maintenance, and strategic development of their assets. | Investing → Asset Management 318 | asset management 315 manufacturer 355 strategy 9379 maintenance 20093 | |
| nelissengxpconsultancy.nl | Nelissen GxP Consultancy | The consultancy offers services across four key areas: Validation Management, encompassing project management and end-to-end system validation; Validation Engineering, which includes creating and executing various testing plans and reports; Asset Management, focusing on system monitoring, change management, and documentation; and Quality Assurance, involving framework setup and documentation review. Nelissen GxP Consultancy specializes in computerized laboratory and production systems, adhering to regulations such as GMP, GLP, and FDA 21 CFR 11, alongside guidelines like GAMP and OECD. The consultant's extensive career includes experience with major pharmaceutical companies such as Organon, Schering-Plough, and Lonza, demonstrating a deep understanding of the industry's standards and requirements. | Software Development & Engineering → Software Testing 75 | validation 69 asset management 315 documentation 452 compliance 506 project management 3423 | |
| pharmafit.nl | Pharmafit Healthcare Innovation | Pharmafit Healthcare Innovation, founded in 2006 by Dr. Ria Müller-Sarwin, specializes in assisting companies with obtaining Drug Product Licenses and maintaining Product Dossiers within the European Union. Dr. Müller-Sarwin, a pharmacist with a PhD and over 25 years of experience in Regulatory Affairs CMC, offers cost-effective and flexible solutions to Drug Regulatory Affairs professionals. The company’s services include project management, training for non-RA professionals, marketing authorization applications, maintenance of drug product licenses, and publishing related to regulatory affairs. | Pharmaceuticals & Pharmacy → Pharmaceutical Services 99 | regulatory affairs 21 consulting 3639 | South-Holland → Rotterdam 25048 |
| qt-int.nl | Qualitech International | The website details Qualitech International’s services, including regulatory affairs support such as classification, registration, and EUAR representation, and FDA services for US market access. Qualitech International highlights a long-standing partnership with QSE Switzerland, leveraging their combined expertise to offer comprehensive representation services across Europe, the US, and the UK. The company emphasizes its global reach, with affiliates in multiple countries and a team of experts with over 25 years’ experience specializing in medical device and IVD development, certification, and registration. | Medical Care & Services → Medical 188 | regulatory affairs 21 medical device 57 translation 1523 training 28133 | |
| rxn.nl | Rxn Regulatory Affairs | The company serves clients ranging from new businesses to large, international pharmaceutical corporations. Founded in 2002 by Rijk Riksen, Rxn Regulatory Affairs is headquartered in Dieren, Netherlands. Their core expertise includes securing and maintaining marketing authorizations and licensing for pharmaceutical products within the Dutch and European markets. | Information Technology → Cybersecurity 1009 | authorization 32 netherlands 1376 consultancy 2596 | Rheden → Dieren 462 |
| yes-pharma.nl | YES Pharma Consultancy B.V. | The company, founded in 1999, has established itself as a dependable and adaptable partner for clients operating within the pharmaceutical and medical device sectors. YES Pharma Consultancy B.V. specializes in regulatory matters related to the OTC market, possessing expertise in the legislation concerning pharmaceuticals, medical devices, cosmetics, and foods. The website details the company’s involvement in both MDD/MDR (medical devices) and eCTD (pharmaceuticals) registration processes, emphasizing compliance with relevant European directives and regulations. | | medical device 57 pharmaceutical 88 compliance 506 regulation 1350 | |
| rmshomecare.nl | RMS Medical Devices Benelux | RMS provides a ‘one-stop-solution’ with a wide range of products and services, including consultancy, training, and technical support. The company has over 30 years of experience in the medical device industry and has grown to become a major supplier for hospitals in the BeNeLux. RMS specializes in the development and distribution of medical equipment, prioritizing patient comfort and quality. The company also focuses on the growing need for solutions for home care. | Pharmaceuticals & Medical Products → Medical Devices 388 | medical device 57 home care 827 consultancy 2596 training 28133 | |