Regulatory Affairs Archives

CMC: Best Practice in Effective IND and IMPD writing

by Nick | Aug 6, 2020 | Regulatory Affairs

Previously, we have discussed the importance of dedicated team for CMC writing as well as project management aspects for effective IND/IMPD writing (previous text here). This time we will focus on technical writing and preparation for it. Also, I will provide some...

CMC: Effective Writing of IND and IMPD

by Nick | Jun 17, 2020 | Regulatory Affairs

Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to...

Biomapas appoints Head of Global Regulatory Affairs

by Nick | May 14, 2020 | Regulatory Affairs

May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution...

Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

by Nick | May 8, 2020 | Regulatory Affairs

Mistranslation of regulatory documents such as common technical documents dossiers, a summary of product characteristics, labelling, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to...

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

by Nick | Jan 31, 2020 | Regulatory Affairs

The trend of outsourcing continues to grow in the life science industry. In particular, the global regulatory affairs outsourcing market was valued at US $5.7 billion in 2018 and is expected to witness a compound annual growth rate of 11.9% over the period to...

Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

by Nick | Aug 2, 2019 | Regulatory Affairs

In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When...

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CMC: Best Practice in Effective IND and IMPD writing

CMC: Effective Writing of IND and IMPD

Biomapas appoints Head of Global Regulatory Affairs

Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

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CMC: Best Practice in Effective IND and IMPD writing

CMC: Effective Writing of IND and IMPD

Biomapas appoints Head of Global Regulatory Affairs

Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

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PV System & QPPV

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