Navigation Links
Ground Zero Pharmaceuticals Announces Expansion of Regulatory Consulting Services to South Africa
Date:10/9/2007

IRVINE, Calif., Oct. 9 /PRNewswire/ -- The advent of biosimilar drugs, new combinations of old ingredients and clinical trial failures in Phase 3 have required new emphasis on "doing it right, the first time." Better use of resources, carefully selected outsource partners and wise allocation of funding lead to fewer failed products in late stages and more success with the FDA review process.

In 2007 GZP added its first South African clients while dramatically increasing the number of Australian and US firms and programs that it represents to the FDA, for mid-discovery through full-scale clinical development and approval.

Several INDs that GZP created and submitted in 2006 received a first-cycle clearance to proceed with clinical trials. A number of pre-IND and end of Phase 2 meetings with the FDA led to successful acceleration of drug and biologic development programs for our clients. Special Protocol Assessments (SPAs) for Phase 3 programs have been submitted and successfully negotiated with the Agency, as well as Orphan Drug and Fast Track status requests. The firm is under contract for two electronic (eCTD) BLAs and three eCTD NDAs and expects additional such programs to be initiated in 2008.

According to Evan Siegel, Ph.D., President and Chief Executive Officer, "The additional resources, combined with zero turnover of our people, allow us to preserve continuity with our long-term clients and to offer the same level of expertise, commitment and rapid turnaround to our new clients. We continue to enjoy the privilege of working with new additions to drug and biologic pipelines while bringing our more than 400 aggregate years' experience in medical product development to bear on the programs of firms new to our partnership. We believe more than ever that bringing regulatory excellence to the table at the beginning of a program, combined with efficient and knowledgeable project management and technical expertise in all disciplines, can launc
'/>"/>

SOURCE Ground Zero Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Groundbreaking Study Gives Hope For Patients With Kidney Cancer
2. Death Wishes Influenced By Ethnicity and Racial Background
3. Fresh Cases of Bird-Flu Prepares the Ground for More Chicken Martyrs
4. Seizure of Low Quantity of Heroin is No Ground for Bail: HC
5. Groundbreaking Asthma Intervention Lessons Help Inner-City Children
6. AIIMS Campus - A Breeding Ground for Mosquitoes
7. A slum in Mumbai – breeding ground for disease
8. Underground Water Contamination In Tripura
9. Adequate Ground Work before a Pandemic Necessary
10. Hospital infections gaining ground in Pennsylvania hospitals
11. Underground Air - Associated With - DNA Damages
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... City, NY (PRWEB) July 29, 2014 ... Head Nurse at Kings County Hospital Center, as a ... recognized with this prestigious distinction for leadership in community ... in the country, spanning virtually every industry and profession, ... powerfully vibrant networking community with over 600,000 members and ...
(Date:7/28/2014)... Ticket Down is a reputable source ... between Manchester City and Liverpool FC at Yankee Stadium ... countless big events since it opened several years ago. It ... Yankee Stadium, however, it has been a popular destination for ... , The Yankees Stadium is the home of the ...
(Date:7/28/2014)... UHY LLP, a member of the global ... International Business – Issue 29. This bi-annual publication features ... current business challenges and key issues faced by companies ... following topics:, , Key industry sectors ... the next five years? Where are growth opportunities to ...
(Date:7/28/2014)... -- Elementary school students seem to be satisfied with the ... new study of school officials. , , New meal standards ... into effect in the fall of 2012. At the time, ... throw away most of their food. But the new study ... case. , , "The updated meals standards are resulting in ...
(Date:7/28/2014)... York, NY (PRWEB) July 28, 2014 ... the body and it’s considered to be conditionally essential ... stress and is an advanced recovery & Immune System ... all the glutamine your body produces, supplementing with additional ... removal of waste products in the body, digestion and ...
Breaking Medicine News(10 mins):Health News:National Association of Professional Women Announces Pamela A. Schulters, Head Nurse at Kings County Hospital Center, a 2014 Professional Woman of the Year 2Health News:Liverpool FC vs. Manchester City Tickets at Yankee Stadium: Ticket Down Reports Huge Demand for Guinness International Champions Cup Tickets in NYC 2Health News:Liverpool FC vs. Manchester City Tickets at Yankee Stadium: Ticket Down Reports Huge Demand for Guinness International Champions Cup Tickets in NYC 3Health News:Uhy International Business Issue 29 Now Available 2Health News:Uhy International Business Issue 29 Now Available 3Health News:Healthy School Lunches Get Thumbs Up From Students 2Health News:Betancourt Nutrition Introduces Glutamine Plus with Sustamine® L-Alanyl-L-Glutamine 2Health News:Betancourt Nutrition Introduces Glutamine Plus with Sustamine® L-Alanyl-L-Glutamine 3
... have uncovered evidence that the abnormal editing of gene messages ... the development of lupus. Scientists hope the finding will lead ... therapy and possibly a new way to treat the disease. ... an enzyme that edits and modifies the messages of genes ...
... At the "World Aquaculture,2008", held on May ... from,the University of Strathclyde, Scotland, United Kingdom, was ... innovative statistical and,epidemiological research methods in sea-lice treatments ... an excellent example of commitment to,the advancement of ...
... money and time spent in intensive care units, researcher ... tubes coated with silver dramatically reduce infections from highly ... breathe through a tube placed through their trachea and ... developing what is called ventilator-associated pneumonia. , "Ventilator-associated pneumonia ...
... Murad, Inc. announced today,the appointment of Fernando Braga, ... for Latin America. In this position, Braga will,develop ... in key,areas, identify prospective partners and create new ... http://www.newscom.com/cgi-bin/prnh/20080519/LAM066 ), "Fernando joins the Murad family ...
... AUSTIN, TexasAging brings a sense of peace and calm, according ... The University of Texas at Austin. Starting at about age ... their younger counterparts. , Catherine Ross and John Mirowsky, professors ... Balance of Emotions in the May 19 issue of Social ...
... Anthem Members in six California, counties - Los Angeles, Alameda, Contra ... of Costs Associated with Medical ... Procedures, ... today the expansion of its industry-leading,transparency initiative into California. Now, approximately 1.8 ...
Cached Medicine News:Health News:Abnormal 'editing' of gene messages may be a cause of lupus 2Health News:Prof. Dr. George Gettinby Honored With Dieter Lutticken Award 2Health News:Prof. Dr. George Gettinby Honored With Dieter Lutticken Award 3Health News:Silver-Coated Endotracheal Tubes Cut Down on Infections 2Health News:Silver-Coated Endotracheal Tubes Cut Down on Infections 3Health News:Murad, Inc., Appoints Fernando Braga, Jr. as Director of International Business for Latin America 2Health News:With age comes a sense of peace and calm, population research center study shows 2Health News:Anthem Blue Cross Introduces Industry's Most Comprehensive Transparency Initiative to California 2Health News:Anthem Blue Cross Introduces Industry's Most Comprehensive Transparency Initiative to California 3
(Date:7/28/2014)... 2014  Dignity Health St. Mary,s Medical Center ... With The Guidelines®-Stroke Silver-Plus Quality Achievement Award for ... American Heart Association/American Stroke Association for the treatment ... cause of death and a leading cause of ... , according to the American Heart Association/American ...
(Date:7/28/2014)... , July 28, 2014 Reportbuyer.com has ... Global Bone Densitometers Market 2014-2018 ... bone densitometry scan is a special type of X-ray ... bone. It is used primarily to detect osteopenia or ... and the risk of fractures is high. The purpose ...
(Date:7/28/2014)... Reportlinker.com announces that a new market ... Portugal Pharmaceuticals and Healthcare Report Q3 ... Includes 3 FREE quarterly updates ... last quarter has led us to revise our ... previously, BMI expects Portugal,s ...
Breaking Medicine Technology:Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 2Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 3Global Bone Densitometers Market 2014-2018 2Global Bone Densitometers Market 2014-2018 3Global Bone Densitometers Market 2014-2018 4Global Bone Densitometers Market 2014-2018 5Portugal Pharmaceuticals and Healthcare Report Q3 2014 2Portugal Pharmaceuticals and Healthcare Report Q3 2014 3Portugal Pharmaceuticals and Healthcare Report Q3 2014 4
... (Nasdaq: VICL ),today is presenting expanded clinical ... Vaxfectin(R) adjuvant may be broadly,applicable in DNA- and ... P. Rolland, Pharm.D., Ph.D., Vical,s,Senior Vice President of ... 8, at the World Vaccine Congress (Lyon, France ...
... Texas, Oct. 7 The Texas Cardiac Arrhythmia,Institute ... selected as one of,only a few sites in ... for a new device to treat persistent atrial ... specializing in heart,rhythm disorders, is a partnership between ...
Cached Medicine Technology:Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months 2Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months 3Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months 4Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months 5Texas Cardiac Arrhythmia Institute at St. David's Medical Center Selected to Conduct Clinical Trial for Device to Treat Atrial Fibrillation 2
... System provides physicians,with an endovascular ... lower patient body temperature, precisely,maintain ... patients to normothermic levels. ,The ... an endovascular,catheter, console and proprietary ...
... the Applied Fiberoptics headlight delivers a homogeneous, ... models to choose from, with both variable ... from 15 mm to 120 mm., ,Each ... any of our quality fiberoptic cables and ...
... "off pump" coronary artery surgery is the ... It is being embraced world-wide by increasing ... are subtle but reduced mortality, stroke, and ... well-established benefits. A cardiac stabilizer is mandatory ...
... balanced, the patented Orion incorporates superior optics ... brilliantly. The fully adjustable headband, made ... sit low on the brow, directing the ... Two clips on the headband position the ...
Medicine Products: