Genedrift

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)
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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 &....

11/17/2025

Regulatory Convergence at CPHI Europe

As innovation grows, regulatory alignment becomes the real differentiator.

At CPHI Europe, one key discussion point is clear: regulatory convergence is not about identical rules—it’s about consistent outcomes.
Authorities like EMA, TMDA, and NAFDAC are strengthening reliance models, yet regional nuances still dictate how data is assessed, interpreted, and accepted.

Global strategy requires local precision.
At Genedrift, we specialize in bridging EU frameworks with APAC and African regulatory pathways—ensuring your global dossier translates effectively across jurisdictions.

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 &....

11/05/2025

Regulatory Compliance: PPB Tightens Enforcement for 2026
Kenya’s Pharmacy and Poisons Board is reinforcing compliance through decisive action.

In its Final Notice (Ref. No. PPB/PDS/VMS/LET/356/2025, dated 15 October 2025), the PPB warned that non-compliant Marketing Authorization Holders (MAHs)—those yet to nominate a Qualified Person for Pharmacovigilance (QPPV)—risk regulatory consequences effective 01 Jan 2026.

These may include:
- Suspension or non-renewal of product registrations
- Denial of re-registration applications
- Refusal of manufacturing or wholesale dealer license issuance

The message is clear: pharmacovigilance is no longer optional—it is operational.

Genedrift supports organizations in building end-to-end compliance programs that include QPPV nomination, safety data systems, and local authority reporting procedures—ensuring no disruption in Kenyan market operations.

Stay compliant before 31 December 2025.
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 &....

11/03/2025

Pharmacovigilance: Strengthening Safety Oversight in Kenya
Are your pharmacovigilance systems compliant with the latest PPB directive?

The Pharmacy and Poisons Board (PPB) of Kenya has issued a Final Reminder (Ref. No. PPB/PDS/VMS/LET/356/2025, dated 15 October 2025) requiring all Marketing Authorization Holders (MAHs) to nominate a Qualified Person for Pharmacovigilance (QPPV) by 31 December 2025.

The QPPV plays a critical role in ensuring continuous monitoring, evaluation, and reporting of product safety across all health products and technologies.
Failure to comply within the stipulated timeline may result in:

- Non-retention of product registrations
- Ineligibility for re-registration
- Suspension or non-issuance of wholesale/manufacturing licenses for 2026

At Genedrift, we assist MAHs and importers in establishing QPPV frameworks, local PV systems, and risk management structures aligned with PPB and WHO standards—ensuring uninterrupted compliance and license continuity.

Learn more: What We Offer (https://genedrift.com/what-we-offer)
Discuss your PV readiness: 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 &....

10/31/2025

EU/US-ready isn’t automatically Africa/Asia-ready.

Plan for language, notarization, legalized docs, and targeted local testing up front.
It’s cheaper than retrofitting after queries start arriving.

Work with the best.
Genedrift helps structure the submission to meet expectations.

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 &....

10/30/2025

Innovation brings visibility. Compliance sustains credibility.

As the global industry gathers at CPHI Europe, the focus extends beyond product pipelines — it’s about the systems behind approvals: data integrity, post-market vigilance, and transparent risk management.

With NAFDAC and TMDA releasing updated GMP and post-market surveillance guidelines in 2025, the regulatory landscape is shifting toward lifecycle accountability.
Approvals are no longer milestones — they’re checkpoints in continuous compliance.

At Genedrift, we embed compliance thinking from dossier design to post-market vigilance — enabling manufacturers to expand globally without regulatory setbacks.

Transform compliance into a growth enabler:
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 &....

10/29/2025

At CPHI Europe, reliance and work-sharing are more than buzzwords — they’re the future of regulatory efficiency.

The TMDA’s 2025 Reliance Guideline and EAC-MRH model show how regulators can shorten approval timelines by leveraging decisions from WHO-listed and EMA-recognized authorities.
But successful reliance requires sameness — in composition, data integrity, and GMP documentation.

For manufacturers, the challenge is practical: How do you adapt a centralized EU dossier into country-specific reliance formats without risking discrepancies?

At Genedrift, we support clients through that transformation — ensuring technical equivalence, unredacted assessment alignment, and consistent regulatory narratives across reliance-based markets.

Build your regulatory reliability beyond borders:
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 &....

10/28/2025

Global pharma is converging, but regulatory expectations remain diverse.

At CPHI Europe, discussions focus on innovation, speed, and access — yet regulatory pathways across regions continue to evolve independently.

EMA harmonization frameworks are influencing ASEAN, TMDA, and NAFDAC models, while local authorities still retain unique dossier, PV, and GMP expectations.

For companies expanding into Africa or Asia, success lies in balancing global compliance consistency with local regulatory precision.

At Genedrift, we specialize in bridging this gap — translating global CTD standards, reliance frameworks, and GMP requirements into region-specific ex*****on strategies that align with local authorities.

Discover how we simplify market expansion beyond Europe:

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 &....

10/27/2025

What ensures justice in regulation—law or compliance?

Just as the High Court upholds justice through evidence, regulatory compliance depends on documented truth.

Under the new NAFDAC GMP 2025, every deviation, investigation, and corrective action must be traceable, signed, and defensible.

A compliant manufacturer doesn’t just follow SOPs—they maintain documentation strong enough to stand in court or inspection.

Genedrift builds such defensible compliance systems—where every audit trail tells your story of 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 &....

10/24/2025

Chhath Puja celebrates discipline, dedication, and purity.

In regulatory affairs, these values resonate strongly:

- Discipline in submission planning
- Dedication to compliance across markets
- Purity in data, truth in reporting

Genedrift applies the same principles—ensuring approvals are built on integrity and precision.

See our approach: What We Offer (https://genedrift.com/what-we-offer)
Connect with us: 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 &....

10/23/2025

Bhaiya Dooj is about trust and safeguarding relationships.

Regulatory success also depends on trust—between global companies, distributors, and Health Authorities.

- Distributors focus on sales goals
- Genedrift ensures compliance and dossier safety
- Both roles complement each other for long-term success

This Bhaiya Dooj, strengthen your compliance partnerships with trust and clarity.

Strengthen your regulatory framework: What We Offer (https://genedrift.com/what-we-offer)
Start a conversation: 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 &....

10/23/2025

This Bhai Dooj, we honor the timeless bond between brothers and sisters—a bond built on love, responsibility, and mutual respect. Just as in our professional lives we stand by our teams and colleagues, in our personal lives too, these relationships remind us of the strength of support and togetherness.

Wishing everyone a blessed Bhai Dooj filled with happiness, prosperity, and the warmth of family.