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Pharmadvice ApS

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Navigating Scandinavian Pharmaceutical Regulations with Expertise Since 2002

As an independent Danish consultancy company established in 2002, this firm specializes in providing expert guidance in the pharmaceutical industry for start-ups, ongoing businesses, and multinational corporations looking to enter the Scandinavian market. With a strong focus on Pharmacovigilance, Regulatory Affairs, Marketing Support & Compliance, and Quality Compliance & RP Services, the company assists clients at every stage from regulatory strategy to marketing authorization applications and life-cycle management. Their team of experienced regulatory troubleshooters is well-versed in European regulations, codes of ethics, and marketing compliance, ensuring that medicinal products are promoted effectively and in full accordance with legal requirements.

Serving as an external Responsible Person, the consultancy performs Good Distribution Practice (GDP) audits and supports wholesalers in meeting their compliance and training obligations. The firm's professional guidance within the complex regulatory landscape simplifies procedures for renewal applications for Mutual Recognition Procedures (MRP) and Decentralized Procedures (DCP), enhanced by recent updates to the CMDh Best Practice Guide. By partnering with this consultancy, clients gain access to valuable resources, ongoing training, industry networking, and selective news updates, all aimed at adding core value to their business operations in Denmark and Scandinavia.

Navigating Scandinavian Pharmaceutical Regulations with Expertise Since 2002

As an independent Danish consultancy company established in 2002, this firm specializes in providing expert guidance in the pharmaceutical industry for start-ups, ongoing businesses, and multinational corporations looking to enter the Scandinavian market. With a strong focus on Pharmacovigilance, Regulatory Affairs, Marketing Support & Compliance, and Quality Compliance & RP Services, the company assists clients at every stage from regulatory strategy to marketing authorization applications and life-cycle management. Their team of experienced regulatory troubleshooters is well-versed in European regulations, codes of ethics, and marketing compliance, ensuring that medicinal products are promoted effectively and in full accordance with legal requirements.

Serving as an external Responsible Person, the consultancy performs Good Distribution Practice (GDP) audits and supports wholesalers in meeting their compliance and training obligations. The firm's professional guidance within the complex regulatory landscape simplifies procedures for renewal applications for Mutual Recognition Procedures (MRP) and Decentralized Procedures (DCP), enhanced by recent updates to the CMDh Best Practice Guide. By partnering with this consultancy, clients gain access to valuable resources, ongoing training, industry networking, and selective news updates, all aimed at adding core value to their business operations in Denmark and Scandinavia.

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