The next best thing to having an experienced consultant on-site 24
hours a day, 7 days a week!
When you enroll with the Online Consultant you get exclusive
access to advice on regulatory obligations, quality systems, product
testing, verification, validation and market access issues. Most importantly
you can ask confidential, specific questions about your regulatory/quality
obligations and get quick, responsive answers from our team of consultants.
Why Enroll?
If you are not a member yet, you're missing out on access
to the following services...
Ask
a question…
A really simple thing to do but so very valuable! Zip a question
off to the Online Consultant and receive a thoughtful personalized
answer!
The Online Consultant can save you hundreds of thousands of dollars
on product testing alone or help you clear up nonconformances quickly
and easily. Questions are limited to 50 words or less and answers
will be no more than 1000 words but we will include example of documents
where appropriate.
Frequently
asked questions…
There are 100s of questions that we have answered over the years.
Each one has the potential to save you time and money!
As an Online Consultant member you get unlimited access to our Frequently
Asked Question database.
Check it often, we update it nearly every single day as something
new is always popping up!
Info
Center
The partners and associates have been part of thousands of audits
through the years and we have amassed a large inventory of checklists
on every thing from regulatory requirements, to quality manuals to
whole quality system audits.
As an Online Consultant member you get unlimited access to our information
database. Check it often - we update it after every audit, as we always
seem to encounter a number of different interpretations.
E-Zine
A good consultant should help you to do things faster, easier and
better. The Online Consultant is no different! Online Consultant members
will get a quarterly newsletter outlining new or changed requirements,
trends in audits and even insight on issues now only on the horizon.
The E-Zine is quite valuable and that is why it is available only
to our clients.
Membership
In order to ensure each of our clients gets the personalized service
they need, memberships are limited.
Annual memberships are $3995.00 USD and provide 24-hour access to
our online information resource center in addition to the most valuable
benefit – "ask a question". You may ask as many questions
as you need to in order to solve your quality or regulatory issue
(subject to our terms and conditions). No minimum purchase of professional
service hours, no consultant travel expenses and no watching the clock!
On-Site
Consulting
Sometimes electronic answers just do not give you what you need.
Perhaps you have an upcoming FDA inspection, or a major client is
coming to audit your manufacturing processes, or investors need to
see progress in regulatory applications.
Online Consultant members have top priority access to our network
of thirty-seven consultants located right around the world who can
work at your location and help your team address specific problems.
On-site consulting is available for an additional fee, tell us what
you need and we will offer a proposal that will deliver within all
of your
expectations.
Technical
and Document Reviews
Have an expert give you important feedback before you make your
regulatory submission. The Online Consultant can review your risk
assessment, design dossier, 510k submission, device license application
or any other regulatory/quality document. We will highlight the strengths
and weaknesses and offer cost effective solutions to address any shortcoming.
That insight will help speed your application through, cutting as
much as six months off an approval or preventing you from repeating expensive
product testing. It is easy to do and not as expensive as you think.
Technical documentation review is available for an additional fee,
tell us what you need and we will offer a proposal that will deliver
within all of your expectations.
