PhoenixSM has been successfully
working with clients in the pharmaceutical, food, and medical
device industries for many years. Here are a few of our success
stories with the client's names omitted to ensure confidentiality.
||"We could not have achieved
such a positive result (on our clinical data audits) without
the "first rate work" of the Phoenix
||"Phoenix has played
an important role in our achieving GCP compliance: In
the past several years, we have successful undergone five
FDA BIMO inspections without any 483s."
||We have provided expert witness consultation to many law firms regarding regulatory requirements. One attorney described a member of our team as follows:
"(Phoenix's) expert witness in our medical device case was terrific, very responsive and testified well in deposition ... a pleasure to work with."|
||Two Phoenix associates
assisted a client with its foreign contract manufacturing
site. One completed a mock FDA audit with a "wonderful
demeanor" and "clear messages" to the client's vendor.
The other associate helped the client build a quality
system and worked with the client to prepare its vendor
for a US FDA inspection. This associate
was described as another "gem" from Phoenix.
||As part of Phoenix's
ongoing electronic submission service, we submitted the
first electronic food additive petition to FDA. This
service expedited FDA's review of the submission.
||We have assisted four
major drug/biologic companies that received consent decrees.
As a result, three out of the four
are no longer under a consent decree. All were allowed
to continue marketing their products
||We have worked with
many clients assisting in the preparation of premarket
submissions to all FDA centers, including combination
products involving more than one center. Our
assistance has lightened our clients' internal workload
and helped facilitate the agency review thereby reducing
time to market.
||We have advised clients
in the preparation of responses to FDA's 483s and Warning
Letters. These efforts have resulted
in positive FDA responses, assuring continued marketing
of the clients' products and preventing additional enforcement
||We have routinely conducted
CGMP/QSR/GCP/GLP audits to include mock FDA PAI audits
for NDA approval. For example, Phoenix has conducted PAI
audits at multiple sites in Japan and Europe.. The client
implemented our recommended corrective action which facilitated
the sites meeting FDA requirements. The
NDAs were approved.
||We have served as an
effective independent auditor of medical device firms
that have been placed on integrity hold. Our
services have helped these firms respond to FDA concerns.
conducted GCP audits for numerous clients and assisted
them with corrective actions. The
result: Successful FDA Bioresearch inspections!
provided regulatory advice to US drug companies on adapting
their development and registration plans to accommodate
EU requirements, including setting up and managing meetings
with EMEA and MHRA. Our European
regulatory insight and assistance has facilitated global
regulatory procedures for its US clients.
|| In Japan, we serve
as a valuable resource for the Japanese pharmaceutical
industry. Using the presentation, "Points for Successful
FDA Inspection," we have provided Japanese pharmaceutical
companies with important facts in how to manage a successful
FDA inspection. Our consulting services
have facilitated many successful PAI inspections for Japanese
||Our Japanese Associate
has published several articles in the Pharm Tech Japan,
Vol. 20 (2004), including the following: "Fundamentals
of FDA Inspection," "Persons Receiving Investigators,"
"How to Deal with Investigators," and "General Affairs
and Concrete Points to be Considered."
These articles have provided the Japanese pharmaceutical
industry with many helpful facts about the US FDA inspection
Charma Konnor, R.Ph., RAC, Executive Director/Consultant,
Devices and Drugs, was named Fellow of the Regulatory Affairs
Professionals Society (RAPS). She was inducted in a ceremony
on September 16, 2008.
Our Associate in Japan, Takashi Yamaoka, wrote an article
about the recent US Food and Drug Administration final rule
[73 FR 51919-51933; September 8, 2008] amending the CGMP for
finished pharmaceuticals, for a popular Japanese pharmaceutical
magazine, Pharm Tech Japan. The article was published
on December 1, 2008. The final rule for the FDA requirements
became effective December 8, 2008.
Want More Information on Successful Risk
Management for Your Device and Diagnostics Company?
Please see the article, Expert
Advises Companies on Successful Risk Management, from
FDA News Device & Diagnostics Letter, featuring
Phoenix's Charma Konnor, R.Ph., RAC, Executive Director/Consultant,
Devices and Drugs.
Reprinted with permission, FDANews © 2005. FDANews.
All Rights Reserved. www.fdanews.com
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