Regulatory Affairs for Life Sciences

A changing French regulatory landscape for innovation

Early access to innovative products is specifically regulated in France and involves regulatory filings to and interactions with the Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the Haute Autorité de Santé (HAS).​

Background and challenges
The « accès précoce » regulations in France for medicinal products have recently changed, replacing the previous frameworks for compassionate use programs (“ATU” or “autorisations temporaires d’utilisation”) and for the procedures “prises en charge temporaires” and “recommandations temporaires d’utilisation” (RTU), and creating “accès précoce” and “accès compassionnel” procedures.
In addition, several French-specific regulations apply to innovative medical devices and medical acts ( “forfait innovation », « prise en charge transitoire », « article 51 »…).

Our customized offer
Our experts assist Life Sciences industries with customised services based on their level of readiness.
This offer includes, but is not limited to, regulatory strategy and compliance, contribution to meetings with French Health Authorities (ANSM or HAS), and assistance with the preparation of regulatory submissions.

A strict, local and changing regulatory landscape

Clinical trials of medicinal products and clinical investigations of medical devices are authorized nationally and the regulatory framework in the EU/EEA is fast evolving with the entry into application of the Clinical Trial Regulation (CTR) and Medical Device Regulation (MDR).​

Background and challenges for regulatory offer for clinical trial/investigation
Clinical development represents a significant portion of the global development of medicinal products and medical devices. It is characterized by strict and ever-evolving requirements at the international, national, regional and local level. New models for clinical development are also emerging, accelerated by the Covid-19 crisis.

Our comprehensive offer
Our seasoned experts provide regulatory expertise and operational assistance before, during and after your clinical trial/ clinical investigation.

Clinical trial applications :
We prepare applications for clinical trials of medicinal products throughout Europe and perform the necessary regulatory maintenance for all entities involved (competent authorities, ethics committees, other bodies).

Clinical Trial Regulation strategy/ readiness :
We help sponsors getting ready for the upcoming implementation of the Clinical Trials Regulation (CTR). We perform the following tasks (non-exhaustive list): training on CTR/Clinical Trial Information System (CTIS), regulatory surveillance, Quality Management System update, change management, regulatory strategy and compliance, and assistance with the preparation of applications.

Clinical investigations :
We prepare applications for clinical investigations of medical devices throughout Europe and assist in the necessary regulatory maintenance for all entities involved (competent authorities, ethics committees, other bodies).

Assistance with study documents :
We provide strategic input, prepare, review and/or adapt documents included in the applications for clinical trials/ clinical investigations, including patient documents.

Regulatory compliance :
We assist sponsors with the numerous, often not-enough anticipated regulatory requirements to be complied with before, during and after the trial, including risk analysis.

Study results posting :
We prepare the necessary datasets from the Clinical Study Report and assist in the posting of study results on behalf of sponsors to EudraCT, clinicaltrials.gov and any required national registries.

Ensure the quality of subcontractors (Contract/Clinical Research Organization ("CRO") :
When necessary, we assist with the supervision, compliance and quality check of the activities delegated to your subcontractors.

Regulatory underpins every stage of the development

Regulatory Affairs encompass a wide range of procedures, from the non-clinical development to the post-marketing stage. Medicinal products developers are asked to comply with diverse, increasingly complex and ever-changing regulatory requirements across multiple geographies.

Background and challenges
Many challenges await developers of medicinal products. They need to know which procedures are available – e.g. for innovative products or orphan drugs, which procedures are mandatory – e.g. pediatric investigation plans in Europe, what are the requirements for writing their regulatory documents or submitting regulatory dossiers, when is the right timing to meet with agencies, etc.

Our customized offer
We assist pharma and biotech companies with all their regulatory needs, with an offer that is constantly evolving based on regulatory requirements and client’s needs.
Services covered include interactions with and assistance with the preparation of regulatory submissions to EMA and national regulatory authorities, pre-and post-Marketing, Authorization Application (MAA), a strategic input and review of regulatory documents and advice on/ review of promotional material.

A regulatory landscape that has become much stricter

The implementation of the European Medical Device Regulation (MDR) and future In Vitro Diagnostic Regulation (IVDR) have substantial impacts for developers of medical devices.

Background and challenges
A few medical devices scandals triggered significant legislative change that led to the EU MDR. This new regulation brings extensive requirements and has far-reaching impacts for many stakeholders, including regulators/notified bodies and medical device manufacturers. The requirements pertain to the mandatory conduct of clinical investigations, data transparency, technical files, vigilance, traceability and labelling, amongst others.

New Regulations Readiness
We have significant expertise with the MDR/IVDR requirements and significant experience accompanying medical device companies with the implementation of and compliance with these new requirements. We will help you bring your company and devices in compliance with these regulations.

Our expertise applied to Regulatory and Quality​

Regulatory compliance and efficient quality processes are paramount in a life sciences company. Our historical experience in internal audits, internal controls, training and regulatory surveillance will be leveraged to assist you with all your needs.

Background and challenges
Regulatory surveillance, training of internal teams, diagnostic and optimization of processes, controls and audits all contribute to a healthy life sciences company, but it may be hard to find the necessary time for given the day-to-day mandatory activities.
We are the world #1 provider of professional services and our French practice is now applying this expertise to the life sciences industry.

Our customized offer
Our experts provide support in many additional fields, including but not limited to, trainings, diagnostic, optimisation and audits of processes with associated transformation, implementation of changes needed, quality audits, Quality Management System support. We will assist you on Corrective And Preventive Actions (CAPA) support, transparency and conflict of interest requirements (in France).
Finally and in development: our team will assist you in the redaction of documents for publication (Policy 0070, Clinical Trials Regulation).

Becoming compliant with evolving data requirements

Data requirements are becoming stricter in the EU with the mandatory use of ISO Identification of Medicinal Product (IDMP) for centralized Marketing Authorisation Applications (MAA) as of 2022. Regulatory Information Management (RIM) systems can help achieve ISO IDMP compliance.

Background and challenges
The gradual implementation of ISO IDMP standards will simplify the exchange of information between stakeholders and enhance the interoperability of systems in the European medicines regulatory network and internationally. Pharmacovigilance, regulatory submissions, clinical trials and good manufacturing practice should benefit from these new standards. The Extended EudraVigilance Product Report Message (xEVPRM), used for the submission and maintenance of data on authorized human medicines, will be replaced by the ISO IDMP compatible format.

RIM systems, in addition to help achieving ISO IDMP compliance, may have additional benefits such as a centralized management of detailed product information, a management of marketing authorisations and registrations, a planning and monitoring of regulatory and submission activities, including commitments, a corrective And Preventive Actions (CAPA) support and an automatic connection of substances, products, registrations, activities, files, submissions and documents.

Our customized offer
Our experts have a significant track record creating awareness and assisting companies with diagnostic, maturity assessment, selection, planning, set-up, assist in the implementation of the desired solution.