Rochelle, Virginia (June 13, 2017) – NDA Partners Chief Executive Officer Earle Martin announced today that the company has entered into a collaboration agreement with Qualiminds Corporate Services of Mumbai, India to jointly provide expert consulting services supporting Biopharma industry manufacturing requirements including expert advice in chemistry, manufacturing and controls (CMC), quality management systems (QMS), and regulatory compliance services. The services are structured to assist clients operating in India and other Asian countries in the design and implementation of manufacturing systems that meet global regulatory requirements, simplify existing cGMP systems to facilitate compliance, maintain CMC data integrity and reliability, and prevent or resolve compliance problems. NDA Partners Expert Consultants in the US will work with Qualiminds staff in India to implement the services, which will be offered alongside NDA Partners’ product development and regulatory strategy and advisory services. The services will include training and onsite audits as well as assessments, design, and planning of manufacturing facilities.
NDA Partners provides a comprehensive range of product development and regulatory services including the design and management of full product development programs and scientific, regulatory and clinical support at all stages from program initiation to product registration in the US and EU. In Asia, NDA Partners provides strategic advisory services to traditional generic products companies seeking to diversify their product offerings in the United States and EU as they begin to develop proprietary products and make the transition into integrated Biopharma companies.
Qualiminds Corporate Services, located in Mumbai, India, offers a comprehensive range of quality management and regulatory support services delivered by a multidisciplinary team of industry, regulatory, and scientific specialists with international exposure and proven track records. Qualiminds provides end-to-end solutions for compliance, “Any Time Readiness” for stringent Regulatory inspections, and regulatory support for Dossier preparation as per quality-by-design (QbD), and Life Cycle Management of drug products. The company was formed in 2016 by former senior industry executives to facilitate understanding of pharmaceutical GMP across the globe, and to enhance the image of India as a quality drug product supplier to the world, which maintains the highest standards in drug product quality in terms of safety, efficacy and purity with international standards of quality systems throughout the life cycle.
According to Phil Goliber, PhD, Partner and Practice Manager for Generic Products, “Our business relationship with Qualiminds will enable NDA Partners to provide clients with improved services in India and other Asian countries through the presence of highly qualified local expert consultants that are closer to their manufacturing sites.”
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer