PTI Team: Dr.Paul E. Wray

PTI TEAM

President

Consultant

Consultant

Consultant

Dr. Paul E. Wray

Dr. Metin Çelik

Dr. Stuart C. Porter

Julia L. Ozyavuz

Dr. Harry G. Brittain

Dr. Paul E. Wray

Please click on any picture or name of your selection!

DR. PAUL E. WRAY

"Our Friend Forever!"

We lost our dear friend Paul E. Wray in November 2002. I was one of the very lucky people who had the opportunity to know him closely. Tears could not be enough to express the sorrow of loosing him and the words would not be enough to express my respect and love for him. He was a great friend and a great scientist. He will live forever in my heart and so will his professional qualifications in this page.

Metin Çelik

Biography

Main Expertise Areas

Biography

Main Expertise Areas

Product Development (J&J)

World-Wide Drug Development
(J&J, Wyeth, Lederle) - 30 yrs

Pre-Approval Expert

FDA, EEC, CPMP

Dr. Wray's Biography

Dr. Wray has over 30 years experience in the fields of pharmaceutical technology, pharmaceutical development and production support at Lederle, Wyeth and Johnson & Johnson where he served as Senior Director, World-Wide, of Process Development/Technical Service, Director of Pharmaceutical Development, Assistant Director of Chemical Production and Manager of Pharmaceutical Pilot Plants.

In these positions, Dr. Wray gained in-depth experience in formulating, developing, evaluating and scaling-up all dosage forms (oral, topical, vaginal, rectal and parenteral.) He has prepared numerous Chemistry, Manufacturing and Control sections of IND's, NDA's and PLA's for the FDA, HPB, CPMP and EC. He also has extensive world-wide experience interacting with regulatory agencies (U.S., Canada, South America and Europe) and has served as chairman of the Research and Development Section of the Pharmaceutical Manufacturers Association and chairman of the Industrial Pharmaceutical Technology Section of the Academy of Pharmaceutical Science.

For the past five years Dr. Wray has been the president of WRAY ASSOCIATES and a principal in a consulting firm where he assists clients in the pharmaceutical and biotechnology industries on a world-wide basis. He assists clients establish develop programs, screen and evaluated dosage forms, scale-up the development dosage forms, initiate commercial scale production and implement the applicable FDA cGMP requirements during these activities. He also has assisted clients in preparing the documentation for these activities and interfaced with the appropriate regulatory authorities in the submission and approval phases. He also has long term experience in auditing facilities and organizations to assess their ability to meet FDA requirements for GMP and PAI. He has prepared companies for more the 35 PAI audits, all of which were successful in a time when the pharmaceutical industry was failing about one out of three times.

Dr. Wray is a member of many professional societies, both national and international, for pharmaceutical science and technology. he was elected as Fellow of both the Academy of Pharmaceutical Science and the American Association of Pharmaceutical Scientists. He has authored and co-authored numerous scientific papers that were published or presented at scientific meetings. He is currently also adjunct faculty at Rutgers University and Temple University where he teaches both undergraduate and graduate level courses.


PTI TEAM
President	Consultant	Consultant	Consultant	Dr. Paul E. Wray
Dr. Metin Çelik	Dr. Stuart C. Porter	Julia L. Ozyavuz	Dr. Harry G. Brittain	Dr. Paul E. Wray
Please click on any picture or name of your selection!
DR. PAUL E. WRAY
"Our Friend Forever!"
We lost our dear friend Paul E. Wray in November 2002. I was one of the very lucky people who had the opportunity to know him closely. Tears could not be enough to express the sorrow of loosing him and the words would not be enough to express my respect and love for him. He was a great friend and a great scientist. He will live forever in my heart and so will his professional qualifications in this page. Metin Çelik

Biography
Main Expertise Areas Biography
Main Expertise Areas
Product Development (J&J) World-Wide Drug Development (J&J, Wyeth, Lederle) - 30 yrs Pre-Approval Expert FDA, EEC, CPMP
Dr. Wray's Biography
Dr. Wray has over 30 years experience in the fields of pharmaceutical technology, pharmaceutical development and production support at Lederle, Wyeth and Johnson & Johnson where he served as Senior Director, World-Wide, of Process Development/Technical Service, Director of Pharmaceutical Development, Assistant Director of Chemical Production and Manager of Pharmaceutical Pilot Plants. In these positions, Dr. Wray gained in-depth experience in formulating, developing, evaluating and scaling-up all dosage forms (oral, topical, vaginal, rectal and parenteral.) He has prepared numerous Chemistry, Manufacturing and Control sections of IND's, NDA's and PLA's for the FDA, HPB, CPMP and EC. He also has extensive world-wide experience interacting with regulatory agencies (U.S., Canada, South America and Europe) and has served as chairman of the Research and Development Section of the Pharmaceutical Manufacturers Association and chairman of the Industrial Pharmaceutical Technology Section of the Academy of Pharmaceutical Science. For the past five years Dr. Wray has been the president of WRAY ASSOCIATES and a principal in a consulting firm where he assists clients in the pharmaceutical and biotechnology industries on a world-wide basis. He assists clients establish develop programs, screen and evaluated dosage forms, scale-up the development dosage forms, initiate commercial scale production and implement the applicable FDA cGMP requirements during these activities. He also has assisted clients in preparing the documentation for these activities and interfaced with the appropriate regulatory authorities in the submission and approval phases. He also has long term experience in auditing facilities and organizations to assess their ability to meet FDA requirements for GMP and PAI. He has prepared companies for more the 35 PAI audits, all of which were successful in a time when the pharmaceutical industry was failing about one out of three times. Dr. Wray is a member of many professional societies, both national and international, for pharmaceutical science and technology. he was elected as Fellow of both the Academy of Pharmaceutical Science and the American Association of Pharmaceutical Scientists. He has authored and co-authored numerous scientific papers that were published or presented at scientific meetings. He is currently also adjunct faculty at Rutgers University and Temple University where he teaches both undergraduate and graduate level courses.