Top 7 Published Articles on Regulatory Services in 2021 That Reveal Deep Domain Knowledge

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The 7 Top Published Articles on Regulatory Services

Here is an exclusive list of articles published by our experts in the regulatory services domain, with an onus on providing key insights that will help further knowledge about trends in regulatory services.

1) It’s now time for your OPDP Submissions to be FDA Compliant | Are you Ready?

Prabu Selvaraj, Senior Manager, Regulatory Operations, Navitas Life Sciences, details how, effective from June 24, 2021, the FDA made it mandatory that Drug Promotion (OPDP) submission types will only be accepted in eCTD format. He also highlighted best practices for 2253 submissions, and detailed how a US based global biopharmaceutical company focused on developing transformative medicines engaged with Navitas Life Sciences to work on their OPDP launch.

Prabu Selvaraj

Senior Manager,
Regulatory Operations,
Navitas Life Sciences

It’s now time for your OPDP Submissions to be FDA Compliant | Are you Ready?

Published in International Pharmaceutical Industry Issue 4 | November, 2021 | Pages 18 – 20

2) Electronic Automation and Process optimization for First Time Right Submissions

Balaji A, Manager, Regulatory Operations, Navitas Life Sciences, explores how automation in the eCTD submission publishing process reduces manual intervention. In this article, he also details how the ability to auto build is achieved using publishing software that generates an XML backbone with metadata. The documents are submission ready with the appropriate PDF properties that follow ICH guidelines.

Mr. Balaji A,

Manager ,
Regulatory Operations,
Navitas Life Sciences

Electronic Automation and Process optimization for First-Time-Right Submissions

Published in Express Pharma magazine | Volume 16 | No. 8 | July, 2021 | Pages 27 - 28

3) Future Ready Labeling – How to Thrive and Survive

Tris Nockles, Labeling Networks Lead, Navitas Life Sciences, details how early evidence is suggestive of a shift towards a bigger focus on strategic value, namely early labeling, digital, and patient centricity.

Tris Nockles,

Manager ,
Labeling Networks Lead,
Navitas Life Sciences

Future Ready Labeling – How to Thrive and Survive

Published on page 29 of Express Pharma Volume 16 | No. 6 | May 2021

4) FDA UDI vs. EU MDR Regulations - Consideration of the Regulations and Implications for EU Labeling

Debi Schimpf, Managing Consultant, Navitas Life Sciences explores the current FDA UDI regulation for medical devices and compares it with the EU MDR/IVDR regulation that came into effect in May 2021. Similarities and differences between the two regulations and the impact that the EU MDR regulation will have on regulatory labeling are outlined in this article, with information on proactive steps for a smoother transition.

Debi Schimpf,

Managing Consultant ,
Navitas Life Sciences

FDA UDI vs. EU MDR Regulations - Consideration of the Regulations and Implications for EU Labeling

Published in Journal for Clinical Studies Volume 13 | Issue 2 | 26 April 2021

5) How can dispensers combat counterfeit medicines

Krishnan S, General Manager for Consulting, and Santosh Narayanan, Senior Business Analyst, Consulting, explore the requirements placed on dispensers post the introduction of the Drug Supply Chain Security Act (DSCSA) to both regulate and enable product traceability from the manufacturer through to the dispenser. The requirements are being rolled out in a phased manner for each of the stakeholders to meet and implement the changes.

Krishnan S,

General Manager, Consulting,
Navitas Life Sciences

Santosh Narayanan BT,

Senior Business Analyst, Consulting,
Navitas Life Sciences

How can dispensers combat counterfeit medicines

Published in BioSpectrum India | 23 April, 2021

6) Brexit and Pharmacovigilance – where may pharmaceutical companies go?

Dr. Philipp Hofmann, MD, Head of Pharmacovigilance and QPPV, explores the potential impact of Brexit to Pharmacovigilance in both the UK and the EU. The article addresses certain salient aspects consequences for Marketing Authorizations, Submission of ICSRs and Aggregate Reports, Signals and Safety Management and EU QPPV and UK QPPV.

Dr. Philipp Hofmann, MD,

Head of Pharmacovigilance, QPPV,
Navitas Life Sciences

Brexit and Pharmacovigilance – where may pharmaceutical companies go?

Published in Pharma Focus Asia | Issue 42 | 2021 | pages 24 – 27

7) Providing a Single Source of Truth

Navitas Life Sciences was named as a Top 10 Pharma and Life Sciences Tech Solution Provider 2021 by Industry Tech Outlook. Marty Boom, Global Head of Regulatory and Safety, Navitas Life Sciences provided insights about our 8 life sciences focused technologies, all developed to meet the unique needs of the industry in the article titled ‘Providing a single source of truth’.

Marty Boom,

Global Head of Regulatory and Safety,
Navitas Life Sciences

Providing a Single Source of Truth

Published Industry Tech Outlook Magazine October, 2021 | Pages 6-10

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