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Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant

Clinical/regulatory consultant to manage FDA drug [IND/DNA] or medical device [IDL/PMA and 510(k)] development programs using a virtual CRO team of consultants.

http://www.larryhofmann.com/

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CONTACTS AT LARRYHOFMANN.COM

LORENZ HOFMANN

205 LAKE●●●●●●●●ARM ROAD

CHAP●●●●HILL , NC, 27516

UNITED STATES

1248●●●●7255
LO●●●●●●●●●●●@YAHOO.COM

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LORENZ HOFMANN

205 LAKE●●●●●●●●ARM ROAD

CHAP●●●●HILL , NC, 27516

UNITED STATES

1248●●●●7255
LO●●●●●●●●●●●@YAHOO.COM

View this contact

LORENZ HOFMANN

205 LAKE●●●●●●●●ARM ROAD

CHAP●●●●HILL , NC, 27516

UNITED STATES

1248●●●●7255
LO●●●●●●●●●●●@YAHOO.COM

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Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant | larryhofmann.com Reviews
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Clinical/regulatory consultant to manage FDA drug [IND/DNA] or medical device [IDL/PMA and 510(k)] development programs using a virtual CRO team of consultants.
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Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant | larryhofmann.com Reviews

https://larryhofmann.com

Clinical/regulatory consultant to manage FDA drug [IND/DNA] or medical device [IDL/PMA and 510(k)] development programs using a virtual CRO team of consultants.

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1

Our Guarantee -- Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant

http://www.larryhofmann.com/guarantee.html

About Dr. Hofmann. Focus on Your IND/NDA. When you work with us, we guarantee the following:. Your IND/NDA or IDE/PMA or 510(k) program will have our full attention and commitment to ensure success. Our consultation fee is at least 20% less than a full service CRO, based on equivalent activity. If for any reason you are dissatisfied with our consultation, you may terminate your relationship with LMH Associates at any time. For more information, or to arrange for a consult at no cost or obligation.

2

Activities -- Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant

http://www.larryhofmann.com/activities.html

About Dr. Hofmann. Focus on Your IND/NDA. Dr Hofmann manages all FDA negotiations of your new drug or medical device. Listed below are activities that Dr. Hofmann and LMH Associates have been involved in:. Lead Pre-IND activities, including: FDA negotiations; IND filing and initiate IND studies. Medical monitor to assure good clinical practices maintained at IND/IDE site. Train for specific study and supervise study monitors (CRAs). Negotiate budgets with and oversee CROs conducting clinical trials.

3

Deliverables -- Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant

http://www.larryhofmann.com/deliver.html

About Dr. Hofmann. Focus on Your IND/NDA. Dr Hofmann completes and delivers your clinical research operations and regulatory assignments on time. Direct clinical operations: IND / NDA medical monitor responsibilities. Medical writing including integrated summaries of efficacy and safety. FDA liaison and IND/NDA (drug) and IDE/PMA (device) strategy development. Drug and/or device master file preparation. IND/NDA and IDE/PMA preparations and filings from U.S. and E.U. firms. 919) 918-7707; Fax:.

4

Focus on Your IND/NDA -- Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant

http://www.larryhofmann.com/focus.html

About Dr. Hofmann. Focus on Your IND/NDA. Dr Hofmann and LMH Associates Focus on All Areas Within Your IND/NDA, IDE/PMA or 510(k) Program. Your program benefits from our experienced network of personal contacts in the drug/device development field. We consider your company's depth of funding to achieve primary milestones as soon as possible. We implement the IND/NDA Action Plan with timely adjustments, ensuring timely completion of activities. 919) 918-7707; Fax:. Site design by Loracs Creations, Inc.

5

Hands-on Experience -- Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant

http://www.larryhofmann.com/handson.html

About Dr. Hofmann. Focus on Your IND/NDA. Lorenz Hofmann, Ph.D., leads LMH Associates' network of independent consultants to give you hands-on experience. We cover every activity of the IND (drug or biologics) or IDE (devices) programs including the Rx products:. We handle programs at any stage, including pre-IND development, IND filing/maintenance and completion, or we develop an FDA approved IND Clinical Plan. Our team of former pharmaceutical and medical device executives is experienced in:.

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Lorenz Hofmann, Ph.D., Clinical and Regulatory Consultant

About Dr. Hofmann. Focus on Your IND/NDA. Your new drug or medical device is too important to leave to just anyone. Dr. Hofmann and LMH Associates can manage your product all the way thru the FDA. Lorenz Hofmann, Ph.D., leads LMH Associates' network of independent consultants to give you hands-on, focused experience with a guarantee. IND filing and maintenance. Regulatory strategy for transition from laboratory to clinical development. FDA drug [IND/NDA]/device [IDE/PMA and 510(k)] registration.

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