נתיב יועצים

24/11/2025

Shalom,

The March 31, 2025 deadline to file Annual Drug Amount Reports has passed. Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, all registrants with listed drug products or APIs were required to report for each NDC.

Now the clock is ticking again. Companies that do not file by December 31, 2025 will appear on the FDA’s public noncompliance list in early 2026.

Compliance made simple with your trusted FDA partner
For over 20 years, Registrar Corp has guided 30,000+ FDA-regulated companies through complex reporting cycles — accurately and on time. As your U.S. Agent, we:
• Identify the reporting data you must submit for each NDC
• Prepare and file accurate Drug Amount Reports and Establishment Re-Registrations
• Maintain and update your listings throughout the year
• Assist with Self-Identification for generic manufacturers and User Fee remittance
• Resolve detentions and regulatory issues before they escalate
• Provide ongoing compliance guidance so you’re always ready for what’s next
Act now to secure your compliance and protect your company’s reputation before deadlines close in again.

Registrar Corp guides your FDA filings with accuracy and care — protecting your compliance and supporting your company’s integrity.

https://www.registrarcorp.com/

15/10/2025

SkillUp provides scenario-based training content using real-world scenarios commonly faced in the food and beverage manufacturing industry, said Registrar.

15/10/2025

📢 Webinar TOMORROW

Introduction to USFDA Medical Device Regulations
📅 October 15, 2025 | ⏰ 10 AM ET
🎤 Presented by: Cornelia Rooks

Perfect for newcomers and professionals seeking a refresher, this webinar offers a clear, practical overview of the regulatory framework governing medical devices in the U.S.

You’ll learn:
✅ How the FDA classifies medical devices
✅ Key pathways for market entry
✅ Essential compliance obligations for manufacturers

Save your spot today: https://hubs.ly/Q03Mm5HX0

01/10/2025

לינק להרשמה : https://register.gotowebinar.com/register/7613569815817948503?source=email%3Futm_source%3Dhubspot&utm_campaign=drugs-webinar-pre-invite-2-drugs-establishment-inspection-10-01-2025&utm_medium=email&_hsenc=p2ANqtz--fPwEpK_VXxsppGYRSwMy48bvOfFXzrw-ZC9v3UTtw60ospTdVsJvsLWwM7Rv10SS5jKNtQ81wgXFDXzuu7L3OXfP2Rg&_hsmi=382934835&utm_content=secure-your-spot-cta-button

30/09/2025

/PRNewswire/ -- Registrar Corp, a leader in food safety training and compliance, today announced the launch of SkillUp, a complete workforce training solution...

28/09/2025

🚨 Upcoming Webinar: How to Prepare for a U.S. FDA Drug Establishment Inspection
📅 Date: October 14, 2025
🕙 Time: 10:00–11:00 AM ET

FDA inspections are a fact of life for drug manufacturers — whether for pre-approval, GMP compliance, post-market follow-up, or complaint investigations. Knowing what to expect can mean the difference between a smooth inspection and costly disruption.

Join us for this exclusive webinar featuring:
Larry Stringer – Former FDA Supervisor & Investigator, Canal Row Advisors
David Lennarz – Registrar Corp
Melissa Sayers (Phillips) Sayers – Registrar Corp

💡 What you’ll learn:
-What investigators do before arriving on-site
-Why FDA inspects facilities & the scope of inspections
-What happens during & after an inspection
-How to prepare in advance to reduce risk
-Best practices for protecting your operations during inspections

This session delivers insights directly from a 30-year FDA veteran who helped revise the Investigations Operations Manual (IOM) — the FDA’s field reference guide.

Don’t miss this chance to strengthen your compliance posture and gain insider knowledge on how FDA inspections really work.

Register now: https://hubs.li/Q03L84Dq0

25/09/2025

Test Your Safety Knowledge About Ready-to-Cook Foods - This simple quiz can help keep you healthy.

08/09/2025

Vodka seltzer brand High Noon has recalled certain 12-packs after some cans were mistakenly labeled at Celsius energy drinks. Food safety and operations experts share how producers can strengthen safeguards to prevent similar quality assurance mishaps.

04/09/2025

Don't put your US market access at risk!!!
Contact Registrar Corp Expert today:
https://www.registrarcorp.com/

02/09/2025

25/08/2025

Drug registration and listing renewals!

The FDA just reported its highest number of drug-quality warning letters in the past five years—driven by a 27% increase in inspections. With scrutiny rising, even small mistakes in your annual drug registration or listing renewal could mean product inactivation, shipment delays, or regulatory action.

That’s why tomorrow we’re hosting an exclusive webinar: Get Ready to Renew with FDA: How to Prepare Before the Renewal Window Opens

In this session, you’ll learn:
• What the FDA expects when it comes to drug registration and listing renewals
• Where companies slip up most often—and how you can sidestep those pitfalls
• Practical ways to keep records accurate and inspection-ready all year long
Don’t let renewal mistakes put your products or reputation at risk—join us tomorrow and renew with confidence

Date: August 26, 2025
Time: 10:00 AM - 11:00 AM ET
Speakers:
• Melissa Sayers, Drug Regulatory Manager
• Christina Jupson, Product Manager
• Sofia Fernandez, Drug Regulatory Specialist

https://register.gotowebinar.com/register/4252262713393538909?utm_campaign=drugs-webinar-pre-invite-4-get-ready-for-fda-renewals-08-25-2025&utm_medium=email%3Futm_source%3Dhubspot&utm_medium=email&_hsenc=p2ANqtz-_elfHQyDHH_yAeaJNquEL7rEUh5OCcri80pJsUiFkaZ8sehWBx1p6n9jXypdQwutH-dqgK7ocJS5fWrJ23VfBiXqrhpA&_hsmi=377346922&utm_content=top-header&utm_source=hubspot