Regulatory Affairs Archives

Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective

by Nick | May 7, 2019 | Regulatory Affairs

Falsified Medicines Directive (FMD) 2011/62/EU which aims to increase the security of manufacturing and delivery of medicines across Europe as well as protect patients and prevent falsified medicines from entering the supply chain has come in force Feb 9th, 2019. With...

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

by Nick | Mar 8, 2019 | Clinical Research, Pharmacovigilance, Regulatory Affairs

On 29th March 2017 United Kingdom (UK) submitted the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that the United Kingdom will become a ‘third country’ from 30th March 2019. Even...

Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

by Nick | Oct 11, 2018 | Regulatory Affairs

Compliance with high-quality standards is a non-negotiable performance parameter in the Pharmaceutical and Medical Device industries. In 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485...

Changing regulatory environment: eCTD submissions to become obligatory as of 2018

by Nick | Sep 10, 2018 | Regulatory Affairs

A new challenge is about to be faced by the Marketing Authorization Holders of medicinal products. Since online tools are becoming a bigger part of our daily lives, the competent authorities are also moving forward step by step. As of 1st January 2018, the European...

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Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

Changing regulatory environment: eCTD submissions to become obligatory as of 2018

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Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

Changing regulatory environment: eCTD submissions to become obligatory as of 2018

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Regulatory Affairs

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PV System & QPPV

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