MMS Named a Finalist in the 2024 Fierce CRO Awards for Leadership in Regulatory Compliance
Proven expertise, knowledge, and processes with flexible solutions to meet rigid compliance requirements
Lorem ipsum dolor sit amet consectetur. Mi feugiat erat facilisis at eget risus scelerisque. Eget in euismod sem facilisis arcu in pellentesque in. Velit quis sed vitae id non leo nunc nibh odio. Sem sagittis interdum at egestas urna faucibus ut dolor. Eget facilisis turpis convallis venenatis aenean. Integer tincidunt urna.
One of the main challenges lies within the demarcation between medical devices and medicines. It is for the manufacturer to initially determine the classification regarding with regards to the primary function of a combination product. FDA and EMA guidance documents include definitions, and examples as well as laying out regulatory provisions for the manufacturer.
Secondly, depending on the regulatory pathway, various regulatory requirements need to be fulfilled for each component of the drug device combination with respect to preclinical testing, clinical investigation, manufacturing and quality control, adverse event reporting, promotion, advertising, and post approval changes.
Lastly, regional differences in regulatory requirements of combination products add another layer of complexity for product developers planning to launch combination products in multiple regions. These regional differences are yet unharmonized despite a few existing initiatives. As a whole, manufacturers in combination product space need good understanding and appreciation of regional regulatory considerations for successful submissions.
- Regulatory Affairs and Submissions Professionals
- Clinical Operations and Clinical Development Resources
- Pharmaceutical and Academic Researchers
- Veteran Affairs Healthcare Providers
Global Auditors to Support Your Compliance needs
To support you better, we provide a full suite of Compliance and Auditing Services, including the ability to perform audits remotely, in-person, or via a hybrid combination of these approaches as required by on-the-ground activities and auditee availability to all Sponsors in the pharmaceutical industry.
Investigator Site Audits
- Routine, Targeted and For-Cause
- Inspection Preparation/Training
- Phases I-IV
- Mock Inspections/Pre-Approval
- Inspections
To support you better, we provide a full suite of Compliance and Auditing Services, including the ability to perform audits remotely, in-person, or via a hybrid combination of these approaches as required by on-the-ground activities and auditee availability to all Sponsors in the pharmaceutical industry.
