Genedrift, Boston, MA (2025)

12/18/2025

“Regulatory is not the real problem” (Contrarian consulting angle)

Most pharma companies don’t have a regulatory problem.
They have a translation problem.

The science team talks in mechanisms and pathways.
The regulatory team talks in guidelines and modules.
The commercial team talks in access and timelines.

And the dossier becomes a 10,000-page “PDF dump” instead of a coherent story.

The turning point for us:
We started every project with one slide:
“If I were the regulator, why would I say YES to this product?”

That single question forced:
• clearer benefit–risk framing
• better alignment between clinical, RA, and PV
• fewer last-minute document “rescue missions”

Most “complex” submissions became much simpler once everyone agreed on that one slide.

I’m seeing this pattern in almost every cross-border project we touch now.

Want to solve your challenges?

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/16/2025

Cross-border approvals (Operational realism)

Our fastest multi-country approval didn’t come from a fancy new tool.
It came from deleting work.

We removed:
• duplicate trackers
• three overlapping status meetings
• and two separate “local vs global” planning docs

Instead, we kept only:
• one live ex*****on board (per market)
• one risk register owned by RA/PV together
• one person clearly accountable for “submission day readiness”

The result?
Fewer emails. Less drama.
And approvals that looked “magically” on time from the outside.

Teams don’t usually fail because they lack frameworks.
They fail because nobody is clearly owning the boring operational details.

This goes against the trend of adding more dashboards and tools—but it’s what actually works for us.

Want to solve your challenges?

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/12/2025

The Future of Regulatory Affairs: Partnership Over Paperwork

In modern regulatory affairs, collaboration outpaces bureaucracy.

Reliance frameworks, joint assessments, and work-sharing models are replacing isolation with trust.
Success now depends on transparent documentation, consistent quality data, and proactive engagement with regulators.

At Genedrift, we view compliance as a partnership—not a process. Our teams collaborate with regulators and clients alike to accelerate approvals and maintain integrity across markets.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/10/2025

Regulatory success isn’t measured by an approval—it’s measured by consistency.

From GMP and PV audits to post-market renewals, compliance now spans the entire product lifecycle.
Authorities such as TMDA and NAFDAC are moving toward dynamic oversight—regular data reviews and unannounced audits.

At Genedrift, we help maintain compliance momentum long after launch—through audit readiness programs, training, and regulatory intelligence.

Work with us to make your applications compliant.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/08/2025

The Future of Regulatory Affairs: Partnership Over Paperwork

In modern regulatory affairs, collaboration outpaces bureaucracy.

Reliance frameworks, joint assessments, and work-sharing models are replacing isolation with trust.
Success now depends on transparent documentation, consistent quality data, and proactive engagement with regulators.

At Genedrift, we view compliance as a partnership—not a process. Our teams collaborate with regulators and clients alike to accelerate approvals and maintain integrity across markets.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/05/2025

Continuous Compliance: Beyond the Approval Letter

Regulatory success isn’t measured by an approval—it’s measured by consistency.

From GMP and PV audits to post-market renewals, compliance now spans the entire product lifecycle.
Authorities such as TMDA and NAFDAC are moving toward dynamic oversight—regular data reviews and unannounced audits.

At Genedrift, we help maintain compliance momentum long after launch—through audit readiness programs, training, and regulatory intelligence.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/03/2025

Inspection Readiness: Every Document Is Evidence

Inspections test systems, not statements.

Every CAPA, deviation, and training record forms your audit defense.
Under the revised NAFDAC API GMP Guideline, traceability and contemporaneous documentation are mandatory.
When your records speak clearly, your compliance story writes itself.

Genedrift builds inspection-ready systems—structured, validated, and defendable.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/01/2025

Classification: The First Regulatory Decision You Make

Getting your product classification right defines every step that follows.

Whether a formulation is a drug, a medical device, or a combination product changes the pathway, dossier format, and responsible authority.
Misclassification leads to redundant testing, incorrect fees, and resubmission delays.

Genedrift ensures correct classification and alignment with definitions across NAFDAC, TMDA, and PPB—before your dossier ever leaves your desk.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

11/27/2025

Data Integrity Defines Regulatory Integrity

A dossier is only as strong as the data behind it.

NAFDAC’s 2025 GMP guidelines emphasize computerized system validation, audit trails, and ALCOA+ principles.
Incomplete records or unverifiable electronic data are now grounds for major findings.

Genedrift helps clients validate digital systems, implement data-governance SOPs, and ensure every entry can stand up to inspection scrutiny.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

11/25/2025

Post-Market Vigilance: The Real Measure of Compliance

Approval isn’t the end of regulatory responsibility—it’s where it starts.

NAFDAC’s 2025 Post-Market Surveillance Guidelines mandate continuous safety monitoring, feedback systems, and structured incident trending.
Delays or gaps in adverse-event reporting can compromise both compliance and patient trust.

At Genedrift, we integrate PV and PMS frameworks from the start of the registration process—ensuring seamless transition from approval to market oversight.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

11/21/2025

PPB Kenya’s QPPV Directive: Compliance is Non-Negotiable

Kenya’s Pharmacy and Poisons Board has issued a final notice—and it’s decisive.

In Notice Ref. PPB/PDS/VMS/LET/356/2025 (15 Oct 2025), the Board directed all Marketing Authorization Holders (MAHs) to nominate a Qualified Person for Pharmacovigilance (QPPV) by 31 December 2025.

- Failure to comply may result in:
- Non-renewal of registrations
- Ineligibility for re-registration
- Suspension of wholesale/manufacturing licenses

Genedrift supports MAHs in QPPV nominations, pharmacovigilance system design, and PPB-compliant safety reporting frameworks—so compliance never interrupts operations.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

11/19/2025

Reliance Pathways: From Review to Recognition

Reliance is not shortcut—it’s strategy.

The TMDA’s 2025 Guideline on Regulatory Reliance allows abridged reviews and verification of sameness to reduce duplication and accelerate access.
But reliance only works when sameness is proven—composition, dossier content, and GMP documentation must align perfectly with the reference authority.

Genedrift helps companies design reliance dossiers that balance global harmonization with local requirements—cutting timelines while maintaining compliance integrity.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

Genedrift

12/18/2025

12/16/2025

12/12/2025

12/10/2025

12/08/2025

12/05/2025

12/03/2025

12/01/2025

11/27/2025

11/25/2025

11/21/2025

11/19/2025

Address

Website

Alerts

Contact The Practice

Shortcuts

Share