YARDLEY, Pa., March 31, 2015 -- Mapi expands Pharmacovigilance and Risk Management capabilities by integrating Mapi's Medical Affairs and global Risk Management strength with the expanded breadth of Pharmacovigilance from a previously announced acquisition.
Pharmacovigilance and Risk Management operations are conducted by a global team that includes physicians, pharmacists, and numerous other Pharmacovigilance professionals that have decades of experience in navigating complex safety requirements throughout the product lifecycle.
"The expansion of our Pharmacovigilance and Risk Management expertise supports the increasing demand from our client base as they seek to balance their commercialization requirements with the increasing need for experienced safety professionals," said James Karis, Mapi's Chief Executive Officer.
In addition to Mapi's robust experience in supporting Post–Authorization studies which include Safety objectives and Mapi's industry leadership in Risk Management Plans (EU-RMP, REMS) routinely requested by regulatory authorities to help control product risks post-approval, the expanded Pharmacovigilance team adds experience supporting Pharmaceutical and Medical Device Safety programs with custom, flexible solutions including:
- Establishing and maintaining a compliant global or regional Pharmacovigilance system, supporting products from first in man studies through to product maturity;
- Providing task-specific services to support an existing Pharmacovigilance system such as ICSR processing, aggregate report preparation, literature searching, etc.;
- Maintaining a Pharmacovigilance System Master File;
- Retaining a Qualified Person for Pharmacovigilance (QPPV) in Europe;
- Preparing application-related safety documents, including RMP or REMs (e.g., for an NDA, MAA);
- Providing 24/7 coverage for medical information services;
- Auditing pharmacovigilance systems for compliance with global regulatory requirements; and
- Providing interactive and tailored training for company employees.
Mapi Group has over 40 years of experience supporting Life-Science companies in utilizing Patient Reported Outcomes measures, Value communications and Health Economics and Outcomes Research, Strategic Regulatory Services, Pharmacovigilance, 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.
Press contact: Media@mapigroup.com