Genedrift

01/05/2026

In the new year, success will be defined by continuity—not just approvals.

Health Authorities increasingly focus on how products are maintained post-approval:

-> Timely safety reporting
-> Controlled variations
-> Ongoing GMP and PV oversight
-> Transparent authority engagement

Organizations that plan for lifecycle compliance early reduce disruption and protect long-term market presence.

At Genedrift, we design regulatory models that support continuity—from first approval through every renewal and inspection.

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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 &....

01/02/2026

A new year brings new regulatory expectations.

Authorities across Africa and Asia continue to strengthen enforcement, expand post-market oversight, and raise expectations on data integrity and lifecycle compliance.

In this environment, regulatory affairs is no longer a support function—it is a strategic pillar for sustainable market access.

At Genedrift, we help organizations align their regulatory strategy with business goals—ensuring growth is supported by compliance, not constrained by it.

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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 &....

12/31/2025

The future of regulatory affairs is proactive, not procedural.

As reliance frameworks, digital submissions, and post-market expectations evolve, the most successful organizations will be those that anticipate regulatory change rather than respond to it.

At Genedrift, we enter the new year focused on helping clients stay ahead—through regulatory intelligence, local expertise, and structured compliance systems.

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 &....

12/29/2025

Before closing the year, it’s worth closing regulatory gaps.

Unresolved variations, incomplete PV documentation, pending renewals, and misaligned GMP records often carry forward unnoticed—until they become regulatory findings.

A structured year-end regulatory review helps organizations enter the new year with clarity, not compliance debt.

Genedrift supports all-year-round regulatory health checks across dossiers, PV systems, and quality documentation—ensuring a clean start to the year ahead.

What We Offer (https://genedrift.com/what-we-offer)
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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 &....

12/25/2025

Christmas is a season of trust, responsibility, and care (and some gifts 🎁)

In regulatory affairs, these values translate directly into how medicines and medical devices are governed—through accurate data, ethical reporting, and continuous safety oversight.

At a time when global supply chains are stretched and markets are interconnected, strong regulatory frameworks ensure that patient safety remains protected, regardless of geography.

At Genedrift, we support organizations in building compliance systems that reflect these principles—transparent, accountable, and patient-centric.

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 &....

12/24/2025

As the year draws to a close, Christmas offers a moment to reflect.

For regulatory teams, reflection often reveals key questions:

-> Are our dossiers consistently up to date?
-> Are post-market obligations actively managed or only reviewed during audits?
-> Are regulatory risks identified early—or only after authority feedback?

Sustainable compliance is built through continuous attention, not year-end corrections.

At Genedrift, we help organizations move from reactive compliance to structured, year-round regulatory governance.

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 &....

12/24/2025

Variations Management Is Where Compliance Is Tested

Initial approvals are visible. Variations reveal compliance maturity.

Label changes, manufacturing updates, supplier changes, and safety updates require disciplined variation management.
Inconsistent submissions or delayed notifications can jeopardize existing approvals.

Genedrift helps organizations design variation control frameworks that are auditable, timely, and aligned with local authority expectations—reducing regulatory risk over time.

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 &....

12/22/2025

Regulatory Intelligence Is a Competitive Advantage

Why do some companies anticipate regulatory changes while others react too late?

Health Authorities across Africa and Asia are issuing frequent guideline updates—often without long transition periods. Companies relying only on published notices risk falling behind.

Effective regulatory intelligence means tracking draft guidelines, implementation signals, and enforcement trends—not just final notifications.

At Genedrift, regulatory intelligence is embedded into our consulting model, helping clients anticipate change and adjust strategy before it becomes a compliance issue.

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 &....