Norwich Pharmaceuticals, Inc., a full-service contract development and manufacturing company, has announced the formation of Norwich Clinical Services to provide clinical testing capabilities that will further expand the company’s third party services. Norwich Clinical Services will offer a complete range of clinical research capabilities including Phase I – IV trials, bioanalytical studies and pharmacovigilance monitoring services.
“The introduction of Norwich Clinical Services underscores our strategic focus to provide customers with a comprehensive solution for all stages of product life cycle management,” said Doug Drysdale, chief executive officer of Alvogen, a company that includes Norwich Pharmaceuticals and Norwich Clinical Services. “We have assembled the highest level of professional expertise to ensure Norwich Clinical Services matches our tradition of unparalleled quality standards and delivers contract pharmaceutical services with everyday excellence.”
Dr. Saral Thangam, MD, PhD, managing director of Norwich Clinical Services, will lead an experienced team of professionals who each have at least 15 years experience in clinical research and life sciences. Dr. Thangam completed her medical training with an Internal Medicine specialization at Christian Medical College, Vellore, and her PhD in physiology was earned at St. John’s Medical College, Bangalore. Prior to joining Norwich, Dr. Thangam was the managing director of Lotus Labs.
“The Norwich reputation is well known and respected throughout the contract pharmaceutical industry for its focus on quality and customer service, and Norwich Clinical Services will meet and support that benchmark with professionalism, efficiency and stringent adherence to GCP, GLP, CFR part 11 and other applicable regulatory requirements,” commented Dr. Thangam. “Our success will be guided by a team that is highly experienced in clinical research, having completed more than 50 clinical trial programs and 2,000 bioanalytical studies.”
Leadership for Norwich Clinical Services also will include Sudhir Pai, Director, and Dr. Fjalar Kristjansson, PhD, Technical Director. Pai was recognized as Entrepreneur of the Year in 2005 by industry magazine Biospectrum, and Dr. Kristjansson holds a doctorate in Pharmaceutical Chemistry with more than 30 years of experience in life sciences. Norwich Clinical Services expects to employ nearly 100 staff during the next 12 months, including physicians, nurses, biostatisticians, quality assurance and bioanalytical specialists, medical writers and pharmacokineticists.
Norwich Clinical Services initially will offer customers pharmacovigilance monitoring supported by Oracle AERS software, bioanalytical studies utilizing API 4000 LC/MS systems, and medical writing services. An independent, 60-bed, clinical trial facility will open later this year that possesses the instrumentation and expertise to conduct pharmacokinetics in healthy volunteers, bio-availability and bio-equivalence studies, drug metabolism studies, dose proportionality studies and multiple dose studies.
Norwich has been serving the pharmaceutical industry for more than 100 years and is expanding its services to offer a full suite of product development and support services, as well as individualized client services in many areas of specialization. Since 2009, the company has successfully opened new facilities for R&D and pilot scale production.
“We are extremely pleased to be generating new products, services and opportunities at Norwich,” Drysdale said. “Norwich Clinical Services will be a pivotal component for growing our business as we continue to expand capabilities to meet the demands associated with new markets.”