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Helena Dahlin
Director Of Regulatory Affairs at Key2Compliance
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Work Experience
Director Of Regulatory Affairs
Sep 2020 - Present · 4 years and 4 months
Symbioteq Kvalitet AB
Aug 2017 - Sep 2020 · 3 years and 1 months
Qa/Ra Consultant - Business Area Manager Ra
Feb 2020 - Sep 2020 · 7 months
Kvalitetskonsult
Aug 2017 - Sep 2020 · 3 years and 1 months
Company Details
51-200 Employees
We make complex things easier - all the way from idea to market - with focus on the Life Science industry providing complete solutions in all aspects of regulatory compliance. Key2Compliance® is a full-service partner that offers complete solutions in all aspects of consultancy and training needs when it comes to: • Medica Device Quality Assurance: Quality system, GXP, technical files, inspections, audits, PRRC responsibility • Regulatory Affairs: Documentation and CE markings, FDA approvals and registrations in the rest of the world • Biological Evaluations and Toxicology: Biological evaluation, material documentation, recommendations, reports and more • Clinical Development: Clinical evaluations, prospective clinical studies, and post marketing studies • Pharma Quality Assurance: Pharma Quality Assurance: GCP, GVP, GMP, GDP and GLP, Quality system, audits, QA-manager etc. • Training and Courses: World-leading training for Life Science industry when it comes to compliance training: in-house, public, on-site, on-location, online, on-demand, printed matters, board games, online documentation library, online testing and eBooks Key2Compliance® - Rely on us! Symbioteq Kvalitet AB and Key2Compliance® were founded as two independent companies 1994 and 1995. Symbioteq focused on consulting in Regulatory and Quality for medical devices and Key2Compliance® soon became a leading company in Training and Education in the field of Current Good Manufacturing Practice (cGMP). After several years of cooperation, the two companies merged in 2020 and formed a joint company called Key2Compliance®, a company within the Symbioteq group. With our strengthened offering, it is our ambition that Key2Compliance® will become the foremost partner for pharmaceutical and medical device companies, not only in Sweden but at an international level. Key2Compliance® has offices in Stockholm, Lund, Gothenburg and Copenhagen.
Year Founded
1994
Social Media
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Industry
Medical Equipment Manufacturing, Metallurgy and mechanical engineering consultants, Technical offices and engineering consultancies, architects, IT, Internet, R&D, Hydraulic plant and equipment engineering consultants, Hospital and physicians' equipment engineering consultants, Business development consultants, Services to businesses, Business Services, Commercial development and foreign contacts consultants
HQ Location
Skeppsbron 44 Stockholm, SE-111 30, SE
Keywords
Quality AssuranceRegulatory AffairsClinical DevelopmentBiological Evaluations & ToxicologyTraining & EducationPharmaceuticalsLife ScienceMedical DeviceClinical EvaluationGxP
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