Genedrift, Boston, MA (2025)

09/25/2025

Priorities: Sales vs. Compliance

Sales and compliance are two different priorities—both critical for success.

📈 Distributors focus on sales growth and market share
📑 Genedrift focuses on regulatory approvals, dossier management, and compliance

When both roles are clearly defined, your commercial launch is smoother, faster, and safer.

👉 Align your compliance strategy with business goals: What We Offer (https://genedrift.com/what-we-offer)

📩 Start your compliance journey: 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 &....

09/24/2025

Updated Guidelines & Recommendations

Market success requires both sales and compliance.

📊 Your distributor drives sales performance
📑 Genedrift monitors evolving guidelines, regulatory updates, and local requirements

Together, both roles are essential—but regulatory intelligence must be handled by experts. At Genedrift, we ensure your submissions meet current expectations, not yesterday’s rules.

👉 Stay ahead of evolving regulations: What We Offer (https://genedrift.com/what-we-offer)

📩 Let’s discuss your next market entry: 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 &....

09/23/2025

Safety of Your Dossier

Your distributor drives market entry.
We protect your dossier.

🌍 Distributors are your partners in sales and distribution
🔐 Genedrift ensures your dossier remains secure, compliant, and always audit-ready

With neutral MAH representation and end-to-end regulatory support, your approvals remain protected throughout the product lifecycle.

👉 Safeguard your submissions: What We Offer (https://genedrift.com/what-we-offer)

📩 Ensure dossier safety today: 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 &....

09/22/2025

Who Should Hold Your MAH?

Who should manage your Marketing Authorization Holder (MAH) responsibilities—your distributor or a dedicated regulatory consultant?

📑 Distributors excel at sales and market growth
⚖️ Regulatory consultants specialize in compliance and dossier safety

At Genedrift, our role as MAH is to keep your submissions secure, compliant, and aligned with Health Authority expectations—while your distributor focuses on driving sales.

👉 Strengthen your MAH strategy: What We Offer (https://genedrift.com/what-we-offer)

📩 Talk to our experts: 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 &....

09/19/2025

Pharmacovigilance & Post-Market Surveillance

Are you audit-ready for local PV requirements?

Across APAC & Africa, requirements vary widely:
🔄 Some markets demand immediate safety reporting
👩⚕️ Local QPPV or national PV officer is mandatory
💻 Local safety databases may be required
❓ Others provide little clarity—yet expect full compliance

Without a strong local PV framework, global firms risk non-compliance, fines, and product suspensions.

At Genedrift, we set up country-specific PV systems, QPPV services, and post-market monitoring—so you meet expectations everywhere.

👉 Build compliant PV infrastructure today: What We Offer (https://genedrift.com/what-we-offer)

📩 Secure your safety compliance: 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 &....

09/18/2025

Local Testing & GMP Inspections

Think your EMA/FDA GMP certificate is enough?
Not always in APAC & Africa.

Many Health Authorities still require:
🧪 Redundant in-country quality testing
🏭 Physical GMP inspections of foreign facilities
⚖️ Revalidation of data already accepted by EMA/FDA
⏳ Extra steps → longer timelines, higher costs

Global firms waste months (and budgets) redoing work that should already be recognized.

At Genedrift, we manage local testing, inspection readiness, and authority engagement—so you stay compliant without unnecessary duplication.

👉 Streamline your quality compliance: What We Offer (https://genedrift.com/what-we-offer)

📩 Let’s simplify your next inspection: 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 &....

09/17/2025

Distributor Dependence & Conflicts

-->Is your distributor holding your product licenses hostage?

In many APAC & African markets:
🔒 Registrations are often tied to local distributors
⚠️ Manufacturers risk losing control if they want to switch partners
⏳ Negotiations drag, delaying launches and renewals
💸 Revenue pipelines stall while disputes are resolved

At Genedrift, we secure your independence through local MAH representation and regulatory ownership structures—so your licenses stay with you, not your distributor.

👉 Safeguard your product registrations: What We Offer (https://genedrift.com/what-we-offer)

📩 Talk to our experts: 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 &....

09/16/2025

Ever submitted a flawless EU dossier… only to face endless queries in Africa or Asia?

We’ve seen it happen:
⏳ “Published timelines” stretch into months of waiting
📨 Queries drag on due to limited HA capacity
🛑 Paper-based submissions mean extra visits & follow-ups
⚖️ No visibility on status—progress depends on who you know

These frustrations cost global firms valuable time, money, and market share.

That’s why Genedrift exists—to bridge expectations vs. reality. With our local representation, regulatory intelligence, and end-to-end support, we make launches predictable, not painful.

👉 Don’t let your next project stall. Learn how we simplify market entry: What We Offer (https://genedrift.com/what-we-offer)

📩 Let’s discuss your next submission: 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 &....

09/15/2025

Why do EMA/FDA-compliant dossiers often fail in Asia & Africa?

Because compliance on paper isn’t always compliance on ground.

📑 ASEAN CTD vs. EU CTD mismatches
📊 Extra demands for translations, notarizations & local testing
🔄 Local QPPV and PV infrastructure obligations
🏛️ Silent expectations from Health Authorities not written in guidelines

Even the most experienced EU/US regulatory teams struggle without local expertise.

At Genedrift, we connect global guidelines with local realities—ensuring your submissions align with what authorities actually expect.

👉 Streamline your submissions and avoid costly delays: What We Offer (https://genedrift.com/what-we-offer)

📩 Ready to ensure seamless compliance? Let’s talk: 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 &....

09/12/2025

⚠️ MAHs Face Deadline for Fosfomycin Insert Correction

Taiwan FDA has corrected the Warnings & Precautions for IV fosfomycin:
👉 “Each gram of this product contains 14.5 mEq sodium.”

📌 MAHs must update package inserts by Jan 31, 2026.

🚨 Missing this deadline risks regulatory action, recall orders, and supply chain disruption.

👉 Full details: TFDA Announcement – Fosfomycin Insert Correction
https://www.fda.gov.tw/TC/siteListContent.aspx?sid=1571&id=49420

Looking for Regulatory Intelligence and Roadmaps

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

09/11/2025

Clinical Trial Review Measures (4 & 27 Aug 2025)

⚠️ Taiwan FDA Tightens Clinical Trial Oversight

Effective Sept 1, 2025, TFDA has revised the Abbreviated Review Procedures for Multinational, Multicenter Clinical Trial Protocols.

📌 New requirements for trial submissions.
📌 Incomplete or outdated protocols = rejection.

🚨 Non-compliance risks trial suspension, delays in global study timelines, and loss of Taiwan as a site.

👉 Full details: TFDA Announcement – Clinical Trials (Aug 4, 2025)
https://www.fda.gov.tw/tc/siteListContent.aspx?sid=4254&id=49395

👉 Full details: TFDA Announcement – Clinical Trials (Aug 27, 2025)
https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=49540

Looking for Regulatory Intelligence and Roadmaps

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

09/10/2025

Pseudoephedrine Safety Re-Evaluation (31 Jul 2025)

⚠️ Pseudoephedrine Safety Under Scrutiny – TFDA Orders Risk Updates

TFDA has published the Drug Safety Information Risk Communication Form for pseudoephedrine-containing drugs.

📌 MAHs must revise package inserts by May 31, 2026.
📌 Updated warnings required → failure to update = non-compliance penalties.

🚨 Ignoring this update risks product recalls, compliance audits, and blocked renewals.

👉 Full details: TFDA Risk Communication Form
http://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=31154

👉 Package insert revision announcement: CDE Regulation Portal
https://regulation.cde.org.tw/10254/4045/70244/regPost

Looking for Regulatory Intelligence and Roadmaps

Visit - genedrift.com
Want to know more - get in touch - cs@genedrift.com

Working with clients to mobilize change, draw regulatory strategies and drive ex*****on helps our client achieve their objectives faster.

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