Mapi incorporates Strategic Regulatory Services to support life-science product Commercialization and Health Research
Yardley, Pennsylvania—3 March 2015 – Mapi incorporates the expertise of CanReg in supporting our clients Regulatory challenges through the drug development and commercialization process.
Mapi Group expands our services to include Global Strategic Regulatory services with the addition of the CanReg Group, incorporated into Mapi through a previously announced acquisition. CanReg is one of North America's largest consulting firms dedicated exclusively to regulatory affairs for life sciences companies. With nearly 100 consultants, advisors and staff, this addition enables Mapi to offer experts with experience working with FDA, Health Canada, Latin American and European regulatory agencies in support of our Pharmaceutical and biotechnology regulatory challenges.
"Mapi is the industry leader in Patient-centred Real World Research, delivers global proficiency in Health Economics, unparalleled depth of experience in Health Research and Post-approval observational studies; with the addition of Strategic Regulatory Services we are now the largest independent company exclusively dedicated to Health Research & Commercialization services. "Said James Karis, Mapi's Chief Executive Officer
CanReg was incorporated in August 1996 and has grown into the leading life-science regulatory consulting organization. This integration enables Mapi clients to benefit from global regulatory support for Pharmaceuticals, biologics, medical devices, natural health products, Over-The-Counter (OTCs), and cosmetics programs, including:
- Global Marketing authorizations (NDA, NDS, MAA)
- Clinical trial authorizations (IND, CTA)
- Regulatory assessment and strategy development
- eCTD Services and Regulatory Publishing
Mapi Group has over 40 years of experience supporting Life-Science companies in utilizing Patient Reported Outcomes measures, Value communications and Commercialization support, Strategic Regulatory Services, Health Research Language Services, and gathering Real-World Evidence on Pharmaceuticals, Biologicals, and Medical devices. Mapi Group is the premier provider of Health Research and Commercialization services to Life-Science companies enabling Market Authorization, Market Access and Market Adoption of novel therapeutics. Visit http://www.mapigroup.com for more information.
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