Regulatory Affairs Archieven

How medical writing supports every stage of the drug’s lifecycle

by Anna Kamocsai | Jun 13, 2025 | Regulatory Affairs

From the earliest phases of development to post-marketing updates, medical writing is the backbone of clear communication and regulatory compliance. But what is medical writing in clinical research exactly? It’s the practice of crafting the essential documents that...

Unlock the full potential of your medical writing outsourcing

by Anna Kamocsai | Jun 6, 2025 | Regulatory Affairs

When clinical timelines are tight and regulatory expectations keep shifting, outsourced medical writing becomes a competitive edge. The right medical writing CRO can help you scale document production, stay aligned with evolving compliance standards, and bring your...

Let’s celebrate success

by Kamile Gruduls | Mar 9, 2023 | Announcement, Clinical Research, Medical Information, Pharmacovigilance, Regulatory Affairs

Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new...

How can a CRO support Mergers & Acquisition

by Nick | Mar 7, 2023 | Clinical Research, Pharmacovigilance, Regulatory Affairs

The role of Contract Research Organizations (CROs) in supporting mergers and acquisitions (M&As) is not a new concept, as CROs have been providing services in this area for several years. However, the demand for these services may have increased in recent years...

The Role of Regulatory Intelligence in Pharmacovigilance

by Nick | Nov 25, 2022 | Pharmacovigilance, Regulatory Affairs

Regulatory Intelligence is a reliable and invaluable tool when it comes to pharmacovigilance. It’s so important because it allows companies to remain up-to-date with the most recent drug safety data and identify new information quickly. What Is Regulatory...

Q&A. How does the conflict between UA & RU impact the pharma industry?

by Kamile Gruduls | Mar 25, 2022 | Clinical Research, Pharmacovigilance, Regulatory Affairs, Webinar

Webinar: How does the conflict between UA & RU impact the pharma industry? Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And with good reason. Russia’s invasion of...

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How medical writing supports every stage of the drug’s lifecycle

Unlock the full potential of your medical writing outsourcing

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How can a CRO support Mergers & Acquisition

The Role of Regulatory Intelligence in Pharmacovigilance

Q&A. How does the conflict between UA & RU impact the pharma industry?

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How medical writing supports every stage of the drug’s lifecycle

Unlock the full potential of your medical writing outsourcing

Let’s celebrate success

How can a CRO support Mergers & Acquisition

The Role of Regulatory Intelligence in Pharmacovigilance

Q&A. How does the conflict between UA & RU impact the pharma industry?

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