{"id":64232,"date":"2026-04-29T13:24:11","date_gmt":"2026-04-29T13:24:11","guid":{"rendered":"https:\/\/oxglobalstg.wpengine.com\/?page_id=64232"},"modified":"2026-07-14T22:34:14","modified_gmt":"2026-07-14T22:34:14","slug":"regulatory-and-compliance","status":"publish","type":"page","link":"https:\/\/www.oxfordcorp.com\/nl-d\/oplossingen\/regulatory-and-compliance\/","title":{"rendered":"Regulatory & Compliance"},"content":{"rendered":"

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Regulatory & Compliance<\/strong><\/h1>\n

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Meer vertrouwen bij regelgevings- en kwaliteitsverplichtingen<\/strong><\/h2>\n

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De eisen op het vlak van regelgeving en compliance veranderen voortdurend voor de productlevenscyclus binnen Life Sciences. Wij helpen organisaties bij het ontwerpen, versterken en gebruiken van regelgevings- en kwaliteitskaders die zorgen voor productveiligheid en -effectiviteit, compliance en risicobeperking en die de ontwikkeling, productie, post-market-activiteiten en bedrijfsresultaten ondersteunen.<\/p>\n

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Onze oplossing voor Regulatory\u00a0& Compliance helpt organisaties om de internationale normen en regelgeving na te leven, op veranderende regelgeving in te spelen en kwaliteits- en risicobeheer te integreren in de dagelijkse bedrijfsactiviteiten.<\/p>\n

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Onze oplossingen voor Regulatory\u00a0& Compliance<\/strong><\/h2>\n

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Wij werken samen met Life Sciences-organisaties om gestructureerde modellen voor regelgeving en naleving aan te leveren die aansluiten bij de productstrategie, de operationele realiteit en de internationale regelgevingsverwachtingen en -vereisten. Met onze benadering integreren we governance, procesontwikkeling en uitvoeringsondersteuning om de controle te vergroten zonder de innovatie te vertragen.<\/p>\n

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Wij ondersteunen de planning en uitvoering conform de regelgeving voor de hele productlevenscyclus door organisaties te helpen bij de afstemming van hun ontwikkelingsactiviteiten, indieningen en verandermanagement op de veranderende eisen.<\/p>\n

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Wij helpen bij de ontwikkeling, implementatie en optimalisatie van kwaliteitsmanagementsystemen door de toepassing van best practices die zorgen voor consistentie, traceerbaarheid en naleving voor alle functies en regio’s.<\/p>\n

[\/dsm_card][dsm_card title=”Voorbereiding op inspecties en audits ” content_horizontal_alignment=”flex-start” image=”https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2026\/06\/reg-comp_03_inspection.png” image_as_background=”off” image_width=”12%” content_padding=”7px|0px|0px|0px|false|false” button_url_new_window=”1″ admin_label=”Inspection and Audit Readiness ” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h3″ header_font=”|700|||||||” body_font_size=”16px” background_color=”#F2F2F2″ custom_padding=”30px|30px|30px|30px|false|false” global_colors_info=”{}”]<\/p>\n

Wij ondersteunen organisaties bij hun voorbereiding op inspecties en audits door de FDA, aangemelde instanties en andere internationale autoriteiten via gestructureerde gereedheidsbeoordelingen, documentatiereviews en de planning van corrigerende maatregelen.<\/p>\n

[\/dsm_card][dsm_card title=”Corrigerende maatregelen en nalevingstransformatie” content_horizontal_alignment=”flex-start” image=”https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2026\/06\/reg-comp_04_compliance.png” image_as_background=”off” image_width=”12%” content_padding=”7px|0px|0px|0px|false|false” button_url_new_window=”1″ admin_label=”Remediation and Compliance Transformation” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h3″ header_font=”|700|||||||” body_font_size=”16px” background_color=”#F2F2F2″ custom_padding=”30px|30px|30px|30px|false|false” global_colors_info=”{}”]<\/p>\n

Wij helpen bij het oplossen van lacunes in de naleving door middel van gerichte initiatieven voor corrigerende maatregelen die leiden tot betere processen, documentatie en controles waarbij verstoringen tot een minimum beperkt worden en kennis overgedragen wordt.<\/p>\n

[\/dsm_card][dsm_card title=”Risicobeheer en data-integriteit” content_horizontal_alignment=”flex-start” image=”https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2026\/06\/reg-comp_05_risk-management.png” image_as_background=”off” image_width=”12%” content_padding=”7px|0px|0px|0px|false|false” button_url_new_window=”1″ admin_label=”Risk Management and Data Integrity” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h3″ header_font=”|700|||||||” body_font_size=”16px” background_color=”#F2F2F2″ custom_padding=”30px|30px|30px|30px|false|false” global_colors_info=”{}”]<\/p>\n

Wij ondersteunen benaderingen voor ge\u00efntegreerd risicobeheer waarmee de kwaliteit, veiligheid en data-integriteit voor alle systemen en activiteiten afgestemd worden.<\/p>\n

[\/dsm_card][dsm_card title=”Facilitering voor regelgeving en kwaliteit” content_horizontal_alignment=”flex-start” image=”https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2026\/06\/reg-comp_06_reg-quality.png” image_as_background=”off” image_width=”12%” content_padding=”7px|0px|0px|0px|false|false” button_url_new_window=”1″ admin_label=”Regulatory and Quality Enablement” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h3″ header_font=”|700|||||||” body_font_size=”16px” background_color=”#F2F2F2″ custom_padding=”30px|30px|30px|30px|false|false” global_colors_info=”{}”]<\/p>\n

Wij ondersteunen het effectieve gebruik van processen en systemen voor de verbetering van de zichtbaarheid, controle en rapportage voor alle nalevingsactiviteiten.<\/p>\n

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Onze capaciteiten voor Regulatory\u00a0& Compliance<\/strong><\/h2>\n

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Wij helpen organisaties bij de doorlopende naleving en het behoud van vertrouwen via strakke uitvoeringsmodellen en ge\u00efntegreerde kwaliteitsprocedures.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ text_font_size=”18px” global_colors_info=”{}”]<\/p>\n

 <\/p>\n

\"\"<\/span><\/b>End-to-End Regulatory Alignment<\/strong><\/h4>\n

Support spanning development, manufacturing, and post-market activities.<\/p>\n

 <\/p>\n

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\"\"I<\/span><\/b>nspection-Ready Operating Models<\/strong><\/h4>\n

Governance, documentation, and controls designed to withstand regulatory scrutiny.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_text_color=”#000000″ text_font_size=”18px” global_colors_info=”{}”]<\/p>\n

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\"\"<\/span><\/b>Integrated Quality and Risk Management<\/strong><\/h4>\n

Alignment across quality systems, risk processes, and compliance reporting.<\/p>\n

 <\/p>\n

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\"\"<\/span><\/b>Scalable Delivery Models<\/strong><\/h4>\n

Support that adapts to product complexity, regulatory scope, and organizational maturity.<\/p>\n

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Waarom Oxford?<\/strong><\/h2>\n

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Organisaties kiezen voor ons omdat we de realiteit kennen van de naleving van de regelgeving en omdat we oplossingen leveren die op best practices gebaseerd zijn, zonder dat dit onnodige belasting met zich meebrengt.<\/p>\n

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Expertise op het vlak van regelgeving voor Life Sciences<\/h3>\n

<\/p>\n

Wij zijn zeer ervaren in het ondersteunen van regelgevings- en kwaliteitsprogramma’s voor wereldwijd opererende Life Sciences-organisaties.<\/p>\n

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Gestructureerde en overzichtelijke benadering<\/h3>\n

<\/p>\n

Duidelijke kaders die zorgen voor consistentie, traceerbaarheid en vertrouwen op het vlak van regelgeving.<\/p>\n

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Multidisciplinaire kennis<\/h3>\n

<\/p>\n

Inzicht in de interactie tussen regelgeving, kwaliteit, productie en post-market-functies.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.21.0″ _module_preset=”default” custom_padding=”0px|||||” global_colors_info=”{}”][et_pb_column type=”1_3″ module_class=”box2″ _builder_version=”4.21.0″ _module_preset=”default” background_color=”#FFFFFF” custom_padding=”30px|30px|30px|30px|false|false” custom_padding_tablet=”30px|30px|30px|30px|false|false” custom_padding_phone=”12px|12px|12px|12px|false|false” custom_padding_last_edited=”on|phone” border_width_all=”0px” border_color_all=”#F2F2F2″ border_color_top=”#e2e2e2″ border_color_right=”RGBA(255,255,255,0)” box_shadow_style=”preset7″ box_shadow_horizontal=”0px” box_shadow_vertical=”0px” box_shadow_color=”rgba(31,75,160,0.64)” global_colors_info=”{}” background__hover_enabled=”on|hover” background_color__hover=”#FFFFFF” background_enable_color__hover=”on” box_shadow_horizontal__hover=”-12px” box_shadow_horizontal__hover_enabled=”on|hover” box_shadow_vertical__hover=”12px” box_shadow_vertical__hover_enabled=”on|hover” border_color_all__hover_enabled=”on|hover” border_color_all__hover=”RGBA(255,255,255,0)” box_shadow_color__hover_enabled=”on|hover” box_shadow_color__hover=”rgba(166,41,55,0.75)”][et_pb_image src=”https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2026\/05\/6-icons-04.png” title_text=”6 icons-04″ align=”center” _builder_version=”4.27.4″ _module_preset=”default” width=”25%” width_tablet=”25%” width_phone=”20%” width_last_edited=”on|phone” custom_margin=”||18px|||” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” header_3_font=”|700|||||||” header_3_text_align=”center” header_3_text_color=”#000000″ header_3_font_size=”19px” header_3_font_size_tablet=”19px” header_3_font_size_phone=”16px” header_3_font_size_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Focus op duurzaamheid en gereedheid<\/h3>\n

<\/p>\n

Nadruk op de samenstelling van nalevingsmodellen die duurzaam, gestroomlijnd, schaalbaar en inspectiegereed zijn.<\/p>\n

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Flexibele samenwerkingsmodellen<\/h3>\n

<\/p>\n

Wij kunnen u op verschillende manieren ondersteunen: met personeel, met gezamenlijk beheer of met volledige leveringsmodellen die op uw behoeften afgestemd zijn.<\/p>\n

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Praktische, op uitvoering gerichte levering<\/h3>\n

<\/p>\n

Wij passen best practices op het vlak van regelgeving en kwaliteit toe op een manier die in operationele omgevingen werkt, waardoor de oplossingen effectief en toepasbaar zijn en aansluiten op de dagelijkse uitvoering.<\/p>\n

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Meer vertrouwen op het vlak van regelgeving tijdens de hele productlevenscyclus<\/strong><\/h2>\n

[\/et_pb_text][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font_size=”18px” global_colors_info=”{}”]<\/p>\n

Effectieve programma’s voor regelgeving en compliance vragen om duidelijkheid, structuur en consistentie binnen de hele organisatie. Wij helpen Life Sciences-teams bij het versterken van hun kaders voor regelgeving en kwaliteit, zodat aan de verplichtingen voldaan wordt, risico’s beheerd worden en de uitvoering met vertrouwen voortgezet kan worden.<\/p>\n

<\/p>\n

Bent u klaar voor een krachtigere regelgevings- en nalevingsbenadering? Neem contact op met ons team om uw behoeften te bespreken.<\/strong><\/p>\n

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Leiderschapsteam<\/strong><\/span><\/h2>\n

[\/et_pb_text][et_pb_divider color=”#FFCB00″ divider_position=”center” divider_weight=”5px” _builder_version=”4.27.4″ _module_preset=”default” width=”8%” module_alignment=”center” custom_margin=”||12px|||” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,3_4″ _builder_version=”4.27.4″ _module_preset=”default” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2026\/06\/Cristel-2.jpg” title_text=”Cristel (2)” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font_size=”18px” custom_padding=”||0px||false|false” custom_padding_tablet=”||40px||false|false” custom_padding_phone=”||40px||false|false” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Cristel Saenen<\/strong>
Solutions Executive, Life Sciences<\/em><\/p>\n

<\/p>\n

Cristel werkt samen met farmaceutische, biotechnologische en medische hulpmiddelenorganisaties in heel Europa om initiatieven op het gebied van regelgeving en compliance binnen sterk gereguleerde omgevingen te ondersteunen. Ze werkt nauw samen met klanten om consultingoplossingen te leveren die kwaliteitssystemen versterken, de voorbereidheid op regelgeving verbeteren en organisaties ondersteunen bij veranderende compliancevereisten.<\/p>\n

<\/p>\n

Met haar uitgebreide ervaring in het ondersteunen van Life Sciences-organisaties begrijpt Cristel de operationele en regelgevende complexiteit waarmee organisaties gedurende de volledige productlevenscyclus worden geconfronteerd. Haar relatiegerichte aanpak en diepgaande branchekennis helpen klanten veranderingen met vertrouwen door te voeren, terwijl kwaliteit, compliance en operationele prestaties behouden blijven.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,3_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2026\/06\/Garry-Bergman.jpg” title_text=”Garry Bergman” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” text_font_size=”18px” custom_padding=”||0px||false|false” custom_padding_tablet=”||40px||false|false” custom_padding_phone=”||40px||false|false” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Gary Bergman<\/strong>
Solution Leader SME, Life Sciences<\/em><\/p>\n

<\/p>\n

Gary is een senior leider op het gebied van regelgeving, kwaliteit en engineering met uitgebreide ervaring in het begeleiden van Life Sciences-organisaties bij complexe uitdagingen op het gebied van compliance en kwaliteit. Hij werkt nauw samen met farmaceutische, biotechnologische en medische hulpmiddelenorganisaties om de voorbereidheid op regelgeving te versterken, governance te verbeteren en duurzame compliance binnen sterk gereguleerde omgevingen te ondersteunen.<\/p>\n

<\/p>\n

Met diepgaande expertise op het gebied van kwaliteitssystemen, leverancierskwaliteit, validatie en de regelgevende vereisten van de FDA heeft Gary organisaties begeleid bij risicovolle remediationprogramma’s, wereldwijde kwaliteitstransformatie-initiatieven en programma’s voor naleving van regelgeving. Hij staat bekend om zijn heldere communicatie, geloofwaardigheid en samenwerkingsgerichte leiderschapsstijl en helpt organisaties zich aan te passen aan veranderende regelgevende verwachtingen, terwijl hij het vertrouwen in de operationele prestaties en duurzaam zakelijk succes versterkt.<\/p>\n

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Nieuwste\u00a0inzichten<\/strong><\/h2>\n

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Op weg naar een succesvolle toekomst met de oplossingen van Oxford.<\/h2>\n

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