Regulatory affairs

Efor provides a complete set of services, covering all aspects of regulatory affairs requirements, to meet the needs of healthcare industry professionals. In addition to our well established expertise working with regulatory authorities, our teams provide pinpoint advisory support to ensure regulatory compliance for all official files.

Our expertise Regulatory Affairs

Medicinal product registration

Efor provides recognized expertise and tailored support to meet the needs of its clients regarding regulatory strategy, writing, coordination, and submission of registration (EU/export), as well as variation files for active substances (APIs) and drugs, including biotechnologies.

Our experts provide our clients with close support throughout the drug life cycle worldwide. Gap analysis between files and site practices, as well as associated remediation plans are examples of activities conducted by our teams in this exercise.

Our highly qualified experts deliver strong results in obtaining, transferring, or modify authorizations for pharmaceutical establishments regarding operations of manufacturing, operating, distributing, storing, etc., as well as the establishment of Site Master Files (SMF).

Our expertise also covers the interpretation and implementation of various regulatory developments, regulatory control of promotional documents, anti-gift law, transparency of links, and other related topics.

Medical device registrations

Our experts assist our clients in all stages of medical device registration in Europe and internationally. Our support aims to ensure regulatory and normative compliance of our clients’ filings. Throughout the medical device lifecycle, our teams provide their expertise on various topics:
  • CE marking for Medical Devices/In Vitro Diagnostic Medical Devices (IVDMD)
    • Technical File compliant with Regulations 2017/745 and 2017/746
    • Design file – ISO 62304
    • Risk management – ISO 14971
    • Usability – IEC 62366
    • Post-Market Surveillance according to the latest applicable guidelines
    • Implementation of unique identification
    • Regulatory watch
    • Support in the implementation of the Quality Management System (QMS) according to ISO 13485
  • US market registration
    • Regulatory strategy
    • Compliance with QMS according to 21 CFR part 820
    • Preparation of 510(K), PMA, DeNoVo files
    • Compliance with QMS according to MDSAP requirements
    • International registration

Clinical, medical and scientific affairs

Our clinical expertise center, composed of experts, PhDs, and featuring its own CRO, offers our customers clinical and scientific skills to support them at all stages of their projects. Our intervention guarantees compliance with the regulations in force in Europe and internationally.
  • CRO

Our CRO offers customized or full-service support for clinical studies in the pharmaceutical, biotech, medical device (MD), in-vitro diagnostic medical device (IVDMD), cosmetic, and consumer health sectors through the following services:

    • Study strategy
    • Scientific and medical writing
    • Clinical project management
    • Monitoring
    • Data Management
    • Statistics
  • Medical and Scientific Affairs

Our services also include :

    • Production of scientific and medical articles, literature reviews
    • Scientific and medical popularization
    • Writing of Module 5 of the CTD
  • Clinical evaluation (MD) / Performance evaluation (IVDMD)

Our experts support our clients in the development and implementation of their clinical/performance evaluation and clinical/post-market follow-up strategies in accordance with Regulations 2017/745 and 2017/746. This includes the writing of:

    • Clinical/performance evaluation plans and reports (CERs/PERs)
    • Summaries of safety and clinical performance/performance (SSCP/SSP)
    • Post-market clinical/performance follow-up plans and reports (PMCF/PMPF)
    • State of the art, scientific validity

Biocompatibility and toxicology expertise

Our Bio-Tox center, with its PhD-level experts, assists our clients in all preclinical aspects related to pharmacotoxicology, for pharmaceuticals, medical devices, and cosmetics. Our expertise covers the following areas:
  • Medical devices:
    • Biological and toxicological evaluation in compliance with ISO 10993 standards in force
    • ADME-Tox study report in connection with MD composed of substances (MD Rule 21)
    • Study of content/container interactions
  • Pharmaceuticals:
    • Analysis and toxicological evaluation of substances according to ICH M7, ICH Q3D, ICHQ3C
    • Pharmacokinetic, pharmacodynamic, safety pharmacology studies
    • Drug interaction studies
    • Regulatory support, through the drafting of Module 4 of the CTD
  • Cosmetics:
    • Pre-toxicological evaluation and validation of formulas
    • Regulatory support in writing the Product Information File (DIP)

Post-market surveillance

Our experts support our clients in the collection and analysis of all post-market surveillance data as required by the various regulations in force. Our intervention aims to ensure optimal monitoring of drugs and/or medical devices in real-world conditions of use, thus confirming the initially assessed benefit-risk balance. This support is structured around:
  • Setting up/reviewing procedures and forms as required by Good Pharmacovigilance Practices and CSP for drugs, and as required by Regulations 2017/745-746 and ISO 13485 for MD/IVDs
  • PMS procedures and forms
  • Vigilance procedures and forms
  • Writing PSURs for your pharmaceutical specialties
  • Writing PMS plans and reports and PSURs for medical devices (MD/IVD)
  • Supporting in signal detection and trend analysis with the expertise of statisticians to provide a methodology compliant with regulatory requirements
  • Assistance in handling vigilance cases
  • Writing or reviewing the PSMF

Our interventions

  • Transition

    The transition to MDR 2017/745 is a challenge for all medical device stakeholders. Our consultants, supported by our Technical Direction, have been able to provide the most relevant solutions to obtain the CE marking for several medical devices under this new regulation.
  • Risks

    Risk management according to ISO 14971 is a central element of the technical documentation required by MDR 2017/745. We have been able to assist our various clients in implementing a methodology adapted to their organization and meeting the requirements of notified bodies.
  • USA

    Access to the US market is an important issue for many of our clients. The 510(k) process is the most common submission pathway. Our teams have been able to collaborate with our multiple clients and the FDA in defining a relevant regulatory strategy, and submitting the 510(k) application.
  • Watch

    In a constantly evolving regulatory environment, our experts provide quarterly reports summarizing the latest regulatory and normative publications related to various healthcare products. These reports are tailored to each of our clients, taking into account the criticality and characteristics of their products.
  • CMC

    Our consultants have worked with various pharmaceutical companies, both on-site and remotely, in the context of authoring CMC (Chemistry, Manufacturing, and Controls) documents and submitting applications for Marketing Authorization and variations.

Efor’s teams have an excellent understanding of the expectations of the competent authorities and notified bodies in order to accelerate the marketing and maintenance of our clients’ products.

– Nicolas THEODORAKOPOULOS – Technical Manager Biocompatibility & Toxicology

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