Regulatory

Affairs

Strengthening regulatory compliance and securing CE marking

Efor supported a Class III medical device manufacturer in the full revision of its technical documentation to meet Regulation (EU) 2017/745 requirements. Our teams led the drafting, updating and compilation of the constitutive documents, including the design files, risk management, GSPR, IFU and PSUR, ensuring their consistency and regulatory compliance. In parallel, our experts assured all preclinical and clinical activities, including BEP/BER, TRA, sterilization validation, cleaning validation and packaging transport validation, as well as CEP/CER, SSCP and PMCF plan and report. This integrated approach enabled the creation of a robust, compliant Technical File ready for assessment by the authorities.

Regulatory support for a pre-filled-syringe combination product — Article 117, EU MDR 2017/745

Efor secured the timely and positive Notified Body Opinion (NBOp) for low-molecular-weight heparin in a pre-filled syringe, classified as a drug–device combination product under Article 117 of Regulation (EU) 2017/745. Our mandate covered the entire regulatory lifecycle: we conducted a comprehensive document review and gap analysis; developed and confirmed the submission strategy through structured engagement with the Notified Body; assembled the full NBOp dossier (Article 117 evidence, Team-NB Position Paper, NB Opinion Template); performed a rigorous compliance check against a dedicated checklist; and managed the formal submission. In parallel, we coached the client’s internal teams and steered multiple Q&A cycles until the notified body’s favorable opinion was secured, transferring best practices that position the organisation for success in future regulatory milestones.

Class IIb electromedical device

Efor supported the manufacturer of Class IIb electromedical medical devices integrating programmable elements, in the preparation of the technical documentation for international market launch. Our team led risk management activities, including cybersecurity, the establishment of the list of critical components, the justification of essential performance and compliance with applicable standards: IEC 60601-1, ISO 14971, IEC 62304, as well as the relevant standards. We also prepared the usability engineering file and the user manual. Acting as an intermediary between the manufacturer and the testing laboratory, Efor facilitated technical exchanges and ensured that requirements were considered during regulatory testing. A dedicated two-day training course on electrical safety and electromagnetic compatibility according to the applicable standards was also delivered to strengthen the client’s understanding and control of the requirements.

Controlling quality risks without impact on the supply chain

Efor supported a pharmaceutical laboratory in the assessment of risks related to nitrosamines across a range of medicinal products, in compliance with EMA requirements and FDA recommendations, including NDSRIs (Nitrosamine Drug Substance-Related Impurities). Our teams also conducted additional analyses on elemental impurities (ICH Q3D) and residual solvents (ICH Q3C), in order to ensure comprehensive risk coverage. Following customer complaints, an unknown impurity was identified and investigated by our toxicology experts, who established its toxicological profile, determined its origin, and assessed its genotoxic potential using silico approaches. This work enabled the risk to be controlled without batch recall and manufacturing processes to be optimized in compliance with ICH requirements.

Ensuring product compliance and securing market launch

Efor supported a major cosmetics group in the assessment of product user safety following an external growth operation. A team of specialized toxicologists conducted an in-depth analysis of substances, ingredients, raw materials and formulas, relying on literature searches and data on analogous products where necessary. Our experts also managed the launch of in vitro tests in order to complete the available data and refine the risk assessment. In parallel, Efor ensured coordination between analytical laboratories and regulatory teams, guaranteeing the consistency of the generated data. This work enabled the preparation of CPSR (Cosmetic Product Safety Report) reports, securing the regulatory compliance of the products and their market launch within the planned timelines.

Transforming the impact of clinical data

Our teams supported a major pharmaceutical group over several months in the development of medico-marketing materials and content intended for patients, healthcare professionals and its sales forces. This assignment was structured around several objectives: to effectively valorize and disseminate the available scientific and clinical data, to facilitate the understanding of the data by various audiences, and to define robust marketing arguments/claims based on scientific evidence. Our approach included identifying and leveraging the most relevant clinical data on the products in order to strengthen and substantiate the key messages. By combining scientific expertise, mastery of regulatory requirements and communication excellence, we enabled our client to optimize the impact of their data, strengthen stakeholder trust and valorize their know-how in a demanding and constantly evolving healthcare environment.