Enter the Danish market with the right evidence, language and accountable owners.
ClinicOps is Danish-led and gives international manufacturers, authorised representatives, research teams and localisation partners a controlled path into Denmark that stays aligned with the wider EU framework.
What the service does
Authority & requirement map
Identify the Danish and EU authorities, public primary sources, registrations, language surfaces and review owners relevant to the declared product or workflow.
Controlled Danish localisation
Map approved English/source content to Danish derivative content, preserve terminology and version provenance, route questions to the qualified owner and document closure.
Evidence reconciliation
Compare declared controlled sources with EUDAMED, regulatory master data, IFU/labelling, SS(C)P, study or operational records placed in scope.
Partner handoff
Route unresolved legal, regulatory, clinical, safety or specialist questions to the right client owner, or to an independent subject-matter expert whose credentials are checked for that engagement. Nothing is guessed.
Denmark first, Europe connected
The Danish Medicines Agency administers medical-device legislation in Denmark and works within the EU MDR/IVDR framework. For medicinal clinical trials in Denmark, the Danish Medicines Agency and ethics committees collaborate through the CTR/CTIS pathway. Where work touches healthcare delivery, authorisation or treatment-place governance, the Danish Patient Safety Authority becomes relevant. Which authorities are in scope is decided per engagement, not assumed.
Primary Danish authorities used in scope
- Danish Medicines Agency — medical devices legislation and guidance
Primary Danish authority source for medical-device legislation, market surveillance and national implementation context.
- Danish Medicines Agency — clinical trials
Primary Danish source for medicinal clinical-trial applications and national CTR/CTIS processes.
- Danish Patient Safety Authority — treatment-place supervision
Relevant where the workflow enters healthcare-delivery governance, authorised health-professional activity or patient-safety supervision.
- National Center for Ethics / Danish research-ethics committees
Relevant to ethical review of research, medicinal trials and clinical investigations where applicable.
- Danish Data Protection Agency
Primary Danish source for data-protection requirements where personal data or health data enters scope.
Connected EU layer
MDR/IVDR & EUDAMED
EU medical-device rules, MDCG guidance and EUDAMED lifecycle data.
CTR / CTIS & GCP
European trial authorisation and ICH-GCP evidence context where a Danish-market question touches trial documents.
AI / EHDS / digital health
EU AI governance and health-data frameworks where they apply to the declared clinical workflow.
Language is controlled evidence, not a side service
ClinicOps treats translation and localisation as part of change control: approved source, target-language version, terminology decisions, reviewer identity, unresolved questions, approval and version closure. ClinicOps coordinates English↔Danish work and specialist review, and never presents a reviewed translation as regulatory approval.
The same discipline covers pharmacovigilance. Global PV systems hit three Danish walls. The local medical journals that GVP Module VI (VI.B.1.1.2) expects marketing-authorisation holders to monitor are written in Danish. Danish-language case reports and narratives need medically literate handling inside statutory reporting timelines. And for DHPCs, the MAH supplies the Danish draft and the Danish Medicines Agency quality-assures it before distributing it. ClinicOps provides that capacity as controlled evidence work — source, target, terminology decision, reviewer, closure — while qualified PV sign-off remains with the client’s safety organisation. No QPPV, deputy or national contact-person role is taken unless explicitly appointed.
Qualified Danish pharmacovigilance capability
A medically trained, natively Danish safety-operations resource that works as an extension of your QPPV system — contract-ready for the 2026 rules. From 12 February 2026, Commission Implementing Regulation (EU) 2025/1466 requires every pharmacovigilance subcontract to set out roles and responsibilities, the method for exchanging safety data, and audit and inspection access, with no onward subcontracting without the MAH’s written consent, and makes risk-based audit of third parties mandatory (Regulation (EU) No 520/2012 as amended, Articles 6(3)–(4) and 13). ClinicOps is set up for exactly that: one named, auditable site your PSMF can list, with a trail your auditors can follow line by line.
Led by Ali Iskandar — Master of Science (MSc) in Medicine (Translational Medicine), Aalborg University — with hands-on pharmacovigilance experience and native Danish.
Medically trained, natively Danish
Master of Science (MSc) in Medicine (Translational Medicine), Aalborg University · ICH-GCP trained · native Danish, professional English · GVP-framework familiarity from operational pharmacovigilance practice. Danish safety work is language-bound: the national PV instruments (Lægemiddelloven and Executive Order 1191/2017) and the local medical literature exist only in Danish, and DHPCs reach Danish clinicians in Danish. Clinical reading and the language, in one reviewer.
Hands-on safety operations
ICSR case processing and MedDRA coding, and safety-database work (Argus, ArisG, EVWEB/EVDAS) in a specialist PV-provider setting — with medically informed English↔Danish case-narrative work. The everyday mechanics of a safety function, done to a controlled, reviewable standard.
Where the Danish need actually sits
Denmark does not mandate a local PV contact person: the Danish Medicines Agency states it will generally not request one, and EMA’s member-state register records that it has never been required of any MAH. You are paying for competence, not a statutory placeholder. The recurring work is Danish-language: journals that GVP Module VI expects you to monitor locally (titles such as Ugeskrift for Læger publish in Danish, outside the reach of a global English search); ICSR narratives and follow-up correspondence in Danish; and DHPCs, where the Danish draft is yours to supply and the Agency can return it if the translation falls short.
Governed, audit-ready method
Engagement terms drafted to Article 6(3): defined roles, a stated safety-data exchange method and timeline, audit and inspection access, no onward subcontracting without your written consent. Every Danish-language item logged with its first-awareness date and handed over on the agreed clock, with periodic reconciliation against your safety database. A justified journal list in writing. Version-controlled, terminology-consistent, human-reviewed — a record your QPPV, your sponsor and an inspector can each follow.
Scope of work (as appointed)
Danish local-literature monitoring with a justified journal list · ICSR and case-narrative language work · Danish DHPC drafts and safety-communication review to the Danish Medicines Agency’s plain-language expectations · Danish-language authority correspondence support · PV-document terminology and version control · controlled safety-information workflows. Scoped in writing to what you appoint — nothing assumed.
Inspect the method first, free and browser-local: Danish literature register · SDEA clause checker · Danish DHPC checker.
Buyer and boundary
Buyer: marketing-authorisation holders, PV service providers and CROs covering Denmark from a global hub. Boundary: QPPV, deputy and national contact-person responsibilities are assumed only where explicitly appointed; medical assessment, causality and signal decisions stay with your safety organisation’s qualified reviewers. ClinicOps is the Danish-language operations layer — precise, accountable, and deliberately not the decision-maker.