Mrinmoy Nag, Author at Lachman Consultant Services, Inc.

Pharmacovigilance at Scale: Managing Complaints and Adverse Events for GLP-1 Products in a High-Volume Market

By John McShane, Mrinmoy Nag and Paddy Costello May 22, 2026 Compliance Pharmacovigilance Regulatory Affairs

The commercial landscape for GLP-1 products is very different than for other pharmaceutical products. Demand is extremely high given the prevalence of obesity, direct-to-patient sales through social media and other channels, and public interest magnified by celebrity endorsement. When these factors overlap, pharmacovigilance (PV) activity increases quickly—and not always in predictable ways. These products are […]

May

TIDES Conference – Recap of Sessions

By Mrinmoy Nag May 19, 2026 Advanced Therapies Biologics Peptides

I had the privilege of attending the TIDES conference in Boston from May 12th to 14th. TIDES is always a standout event where attendees can hear about the latest advances in oligonucleotide and peptide therapeutics, along with valuable insights into the evolving landscape of drug development and manufacturing. This year was no exception, with a strong […]

Feb

Ensuring Data Integrity at Contract Laboratories: Who is Accountable?

By Mrinmoy Nag Feb 13, 2025 Compliance Data Integrity Regulatory Affairs

Deflecting responsibility is a timeless tactic for the young. While it was easy to simply point the finger and say, “I didn’t do it, they did,” as children, this approach is not viable in the life-sciences industry when things go awry. In this sector, we can’t simply transfer our responsibilities without written agreements and clear […]

Aug

Pharma, What Can We Learn from the Infamous CrowdStrike Outage?

By Mrinmoy Nag and Patrick Day Aug 28, 2024 Compliance FDA Regulatory Affairs Supply chain

A couple of months ago, when we returned from Barcelona to San Francisco, it was impossible to check in online for some reason. Then the news broke about flight disruptions due to the CrowdStrike software update! Some flights, including ours, were only a couple of hours delayed. However, many more passengers were affected even further […]

Aug

Never Too Early to Talk to Your Employees About GMP - Lachman Blog

It’s Never Too Early to Talk to Your Employees About GMP!

By Mrinmoy Nag Aug 08, 2024 cGMPs Compliance

About eleven years ago, when I was dropping my son off at school before going to work, I was taking a sip from my coffee mug. From the back seat, my son shouted, “Daddy, don’t drink and drive!” I was surprised – did he learn that in school? He had started kindergarten barely a month […]

Sep

OOS: Whose Line is it Anyway? The Contract Testing Laboratory’s or Sponsor’s?

By Mrinmoy Nag Sep 01, 2023 ANDAs Biosimilars BLA Compliance Laboratories NDA OOS Regulatory Affairs

When it comes to investigating OOS results, a clear line should be drawn between the responsibilities of a contract testing laboratory (CTL) and that of the manufacturer/sponsor. Before we come to the testing part, here are some questions (not all inclusive) to be asked by your firm before selecting a CTL for outsourced testing: (1) […]

Jun

Highlights from the Recent European Biomanufacturing Summit

By Mrinmoy Nag Jun 06, 2023 Biologics Biosimilars

The European Biomanufacturing Summit was held on May 31 and June 1, 2023, and was attended by industry leaders from multinational biotech and biologics companies, largely from Europe. The agenda on the first day of the conference included topics related to modernization and digitization of the pharmaceutical industry. The presenters talked about challenges in transforming […]

Mar

Are You a “Bee-Watcher-Watcher”?

By Mrinmoy Nag Mar 09, 2023 Compliance FDA Quality Regulatory Affairs

Have you ever wondered why, in many airports across different countries, there are multiple random security checks after the initial check at the entrance and before boarding the plane? Do all these intermediate checks make flying much safer? Are intermediate checks required because the initial check may not be trustworthy, or are they intended to […]

Dec

Analytical Method Validation, Verification, or Qualification – What to use and when?

By Mrinmoy Nag Dec 23, 2022 Analytical Methods Compliance Drugs Regulatory Affairs

Analytical development and/or QC groups at early-stage pharmaceuticals and biopharmaceuticals often ask themselves about the level of level of confirmation of suitability required for their methods. Often the term ‘validation’ is used without understanding the full implications of the term. Sometimes, the terms validation, qualification and verification are used interchangeably. While ‘validation’ is well understood […]

Sep

To Average or Not to Average, That is the Question?

By Luis Collazo-Malave and Mrinmoy Nag Sep 30, 2022 Compliance FDA OOS Regulatory Affairs

Earlier this year, we posted about FDA’s new revision for the OOS Guidance for Industry. The new revision allows ‘averaging’ results from a pool of replicate results even though one of them is OOS for ‘certain circumstances.’ This was the most significant change in this revision. So the question is, can you always average? If […]