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FDA Enforcement Continues to Rise

Posted by hrs.jmorgan on May 28, 2013 at 3:25 PM Comments comments (31)

While news reports discuss the diminishing funds for many government programs, it seems that the FDA remains unaffected.  In fact, FDA Warning Letters continue to rise in number, indicating that the need for compliance to the regulations is more important than ever.  While it may be human nature to take on a "Big Brother is out to get us" attitude, the facts remain that the recipients of these enforcement actions have simply had deficiencies in their Quality Systems.

The ripple effects have extended to web sites that make health claims for products that have not been properly managed in today's regulatory environment. And it is important to note that the FDA need not send an investigator to the place of business.  A few key taps can begin a web review that can effectively shut down a burgeoning web business.

Another area that previously flew under the radar is the neutriceutical or dietary supplement industry, where regulations are similar to that of medical device and pharmaceutical companies.  However, unliike the device and pharma regulations, those for dietary supplements are shown in a  reader-friendly Q and A format in addition to the stiffly-penned regulations. (see  As a result of increased scrutiny, Warning Letters to dietary supplement manufacturers have steadily increased over the past three to five years.

In the FDA's own words:

A Warning Letter is informal and advisory. It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action on which it can be sued.

Worse actions can wait in the wings, including recall, seizure, injunction, administrative detention, civil money penalties,and/or prosecution to achieve correction.

It is therefore more important than ever that manufacturers understand the requirements for legally providing medical devices and dietary supplements and make the correct enhancements and corrections to their Quality Management Systems to avoid the potentially inevitable Warning Letter.

Hawai'i Regulatory Services can perform a regulatory Gap Analysis or Web Site Regulatory Review.  Please use the Contact Us form in this website.  Hawai'i Regulatory Services can help.

QSDLease - Document Control Cost Savings

Posted by hrs.jmorgan on December 17, 2012 at 4:30 PM Comments comments (3)

QSDLease is a service provided by Hawai’i Regulatory Services and is extremely helpful and efficient for small companies, start-ups and 21 CFR 111-regulated companies.  Small clinics and physicians' offices can even benefit.

Here'show it works:

  • Hawai’i Regulatory Services will provide an interview with the client using a form to determine the extent of the business Quality System needs.
  • The client returns the form to Hawai’i Regulatory Services indicating the best time to call or contact.
  • All the above is freeof charge.
  • After a clarification phone interview, Hawai’i Regulatory Services can then propose acustom Quality System Documentation system and the start-up fee.
  • The client then approves the plan and is billed for half of the start-up fee; the remainder isdue on publication.
  •  The documents are customized and distributed to the client on a secure server for review.  If further customization is needed, it is free of charge.

For a monthly lease, Hawai’i Regulatory Services will maintain the document system and update as needed based on changing client needs. The  lease fee is based on the number and complexity of the documents involved. Updates may also be suggested by Hawai’i Regulatory Service based on new regulations, trends, and regulatory intelligence.

It's a one-stop way to maintain compliance virtually without the need for FTEs and associated overhead.  QSDLease is perfect in today's economic climate, and a huge cost savings for small and start-up companies.

Just fill in the Contact Us section of this web site and you're on your way to savings!

© 2012-2013 Hawai’i Regulatory Services


THE GAP ANALYSIS - Questions and Answers

Posted by hrs.jmorgan on January 12, 2012 at 5:45 PM Comments comments (0)

What is a GAP Analysis?

A GAP Analysisis a tool that helps a company determine the steps to be taken in moving from acurrent state to a desired future-state. This helps provide the company withinsight into areas which could be improved. At its core are two questions:"Where are we?" and "Where do we want to be?"


What does it consist of?

A GAPAnalysis consists of two phases. PhaseOne involves determining, documenting and approving the variance betweenregulatory requirements and current capabilities. This is done by on-site andoff-site evaluation and communication with the client in an organized,systematic audit.


Phase Two involves preparing and implementing plansto fill the gaps.  This involvesdevelopment of systems compliant with the Quality System Regulation (21 CFR 820in the US) and/or ISO 13485 and MEDDEV (EU). These systems lead to documentedprocedures and instructions the company uses as a roadmap for marketing medicaldevices in the US and EU.


Why is it Useful?

The GAPanalysis provides a foundation for measuring investment of time, money andhuman resources required to achieve a particular outcome. It is designed to bea proactive approach to management of the design, verification, manufacture, qualitycontrol, quality assurance, distribution and customer interaction for themedical device.


Virtual - A Huge Cost-Control Benefit

Posted by hrs.jmorgan on January 12, 2012 at 5:40 PM Comments comments (3)

Today's economy means everything must be viewed from a new perspective.  The term "Bang for the Buck" was just a buzzword with little substance over the past 15 to 20 years.  Now it's a matter of survival.



In the past, when firms required outside assistance with start-up, new challenges or maintenance of old challenges, they hired consultants for on-site and often full-time.  In many cases, the "hired gun" was flown in several times a month, provided a rental car budget, hotel and meals and often on-the-road travel time. This easily could run up to $2000.00 per week in addition to the hourly fees. Just as often the "consultant" was recently unemployed from industry and was looking for a paid interview and hoping that a full-time position would be offered. Companies deserve better.



Today, communicative  technology abounds, yet there are still companies that insist on a daily presence in their choice of consultants. Why? Because that's the way things were always done.  Besides, if they're right under your nose, you know they're working, right?  Wrong.



It's not that initial and as-needed consultant presence is unnecessary.  Certainly at the beginning of a project, at critical milestones, or during troubleshooting being on-site is critical so that a mutual understanding of the issues and the identities and needs of the client can be assessed. But with email, text messaging, video conferencing, conference calling at our fingertips, a constant on-site presence seems an illogical expense with no more Bang for the Buck.

Hawai'i Regulatory Services specializes in off-site team assistance as we assist the client through their challenges and help them to achieve goals. We have even successfully submitted 510(k)s for international clients strictly by virtual contact. 



Start-up companies have grown to appreciate the cost savings of this approach.  Our Quality Systems program, QSDLease, offers a library of customizable Quality Systems documents that we maintain for an initial charge and a monthly maintenance fee, saving your company the substantial cost of development and management in-house.  We also offer variable monthly retainer-based consultations that can be initiated as easily as typing an email or picking up a phone - all without the long-term committment, overhead and in-air delays. 

It's the new way to work, and the best way to save.