A-pharmaconsult services: Regulatory Affairs (Drugs & Medical Devices)

A-pharmaconsult specializes in consultancy services to support pharma manufacturing and medical devices. A key element of its offer is as a Regulatory Affairs partner, helping life sciences clients to ensure standards compliance for drugs and medical devices.

The A-pharmaconsult regulatory offer includes solutions that help life science companies to manage the complexities of the regulatory environment in a global healthcare sector as well as working in partnership to shape and implement regulatory strategy, to deliver reduced cost, increased efficiency and more effective marketing by maintaining quality and compliance for drug and medical device products.

Drug products

A-pharmaconsult serves human and veterinary medicine markets with regulatory services and advice that take account of an increasingly complex environment for global market health products, due diligence in mergers, acquisitions and licensing, and constantly evolving regulations, standards, and guidelines.

Its drug-related services include preparation and maintenance of Marketing Authorization Application (MAA), gap analysis, research and writing services covering drug, clinical and non-clinical modules, chemistry manufacturing controls (CMC), regulatory strategy, product information, and expert reports.

An experienced regulatory team supports clients in preparing gap analysis and updating the regulatory documentation for their drug products.

Gap identification and assessment of potential regulatory implications allows clients to take preventive measures to ensure regulatory conformity with EU requirements.

Medical Devices

Effective marketing of Medical Devices requires full control of related Technical File, and Quality Management System (QMS). In this field, A-pharmaconsult can offer:

• Solutions adapted to EU requirements for CE marking
• Compliance with current ISO standards including 13485, 14971, 10993 and other guidelines as Medical Device Coordination Group (MDCG).
• Transition to compliance with the new European medical devices regulation EU MDR 2017/745.
• Whole lifecycle support from the development to the marketing of medical devices, including all maintenance activities and post-market surveillance
• Correct classification and positioning of medical devices
• Strategy and regulatory/normative monitoring
• Assistance to development: Product Spec Design, specifications, audit, coordination with subcontractors
• Preparation/maintenance of Technical File documentation: product life cycle, plan/risks management report, Clinical Evaluation Plan/Report (CEP/CER), Biological Evaluation Plan/Report (BEP/BER), Risk Management Plan/Report, Usability Plan/Report, Post-Market Surveillance and clinical follow up (PMS/PMCF) Plan/Report, PSUR periodic safety updates, and documentation for Price/Reimbursement under the French HAS regime.
• Support for the Implementation / Compliance of Quality Management System: document management, training, audits, management of complaints, change controls and other nonconformities.

A-pharmaconsult work in collaboration with clients in development of QMS and the CE-mark registration of their devices as well as liaising with Notified Bodies during audits and any follow-up procedures.

Resources

Click on A-pharmaconsult Regulatory Affairs Services  for further information.