Regulatory Affairs and Toxicology

Qualilab has designed a service offering that adapts to your needs and your products:

• Regulatory affairs services for medicines, medical devices, and cosmetics
• Toxicology services for pharmaceutical active substances, extractable and leachable substances, cleaning validation, and impurities
• Biological and toxicological risk assessment services for medical devices, in vitro devices, and combination products
• Toxicology services for cosmetic products

OUR REGULATORY AFFAIRS SERVICES

Our regulatory affairs offers cover the following areas and services:

MEDICINAL PRODUCTS

• Assistance with registration strategy
• Coordination of studies
• Drafting of MAA dossiers (Module 3)
• Preparation of product information documents (SmPC, package leaflet, and labelling)
• Non-clinical toxicological assessments (impurities, excipients, residues)
• Publishing and submission of dossiers

MEDICAL DEVICES

• Drafting of technical files in compliance with Regulations (EU) 2017/745 and 2017/746, MDR (Medical Devices/IVDs/Combination Products)
• Biological Risk Assessment (BRA) and Toxicological Risk Assessment (TRA)
• Clinical evaluations (CEP/CER)
• Post-market surveillance (PSUR, PMCF, PMS)
• Risk management documents, EGSP
• Usability evaluation
• Regulatory monitoring
• Support for interactions with notified bodies
• Regulatory roadmaps

COSMETICS

• Drafting and compliance of the Product Information File (PIF) in accordance with Regulation (EC) No. 1223/2009
• Conducting toxicological safety assessments of ingredients and formulas
• Review of labelling and claims
• Notification of cosmetic products on the CPNP portal
• Regulatory monitoring

OUR TOXICOLOGY SERVICES

We offer regulatory and scientific expertise in toxicology for the pharmaceutical industry, in compliance with Good Practices (BPx/GxP), EMA guidelines, and ICH standards.
Our toxicology offers cover the following areas and services.

PHARMACEUTICAL ACTIVE SUBSTANCE (API)

• Toxicological assessment of APIs, including plant-derived substances when used as active ingredients or excipients
• Analysis based on absorption, distribution, metabolism, and excretion (ADME) data, as well as pharmacological and toxicological data

EXTRACTABLE AND LEACHABLE SUBSTANCES (E&L)

• Toxicological evaluation of substances from primary packaging materials or manufacturing processes

CLEANING VALIDATION

• Preparation of Permitted Daily Exposure (PDE) assessment reports to define toxicological limits associated with each active substance handled at multiproduct pharmaceutical manufacturing sites.

  These reports make it possible to determine acceptable residue levels during product changeovers and to limit the risks of cross-contamination, while ensuring an acceptable level of safety for all medicines manufactured at the site.

IMPURITIES

• Risk assessment of impurities (residual, degradation) in APIs and finished pharmaceutical products
• Calculation of toxicological thresholds such as PDE

OUR BIOLOGICAL AND TOXICOLOGICAL RISK ASSESSMENT SERVICES FOR MEDICAL DEVICES, IN VITRO DEVICES, AND COMBINATION PRODUCTS

We support manufacturers of medical devices (MDs), in vitro diagnostic medical devices (IVDs), and combination products (i.e., devices incorporating a pharmacologically active substance) in their regulatory, strategic, and scientific processes, in compliance with Regulations (EU) 2017/745 and 2017/746 and with ISO 10993 standards.
 

Our services include the elements detailed below.

BIOLOGIQUE EVALUATION PLAN

The biological evaluation plan sets out the biological evaluation strategy for a medical device. It is based on a risk-analysis approach that takes into account the nature of the materials, the duration, and the type of contact with the human body.

It makes it possible to identify existing data, assess their suitability with biological safety requirements, and then, based on the risk analysis, define any additional tests required or justify their absence.

BIOLOGICAL EVALUATION REPORT

The biological evaluation report is the final synthesis of the strategy defined in the biological evaluation plan.

It compiles, interprets, and justifies all available data, including the results of tests carried out to address any gaps in biocompatibility. It describes the methods used, the results obtained, and incorporates a biological risk analysis in accordance with ISO 10993-1.

It concludes on the overall acceptability of the biological safety of the medical device and constitutes an essential component of the regulatory submission dossier.

TOXICOLOGICAL EVALUATION REPORT

The toxicological evaluation report is prepared based on the results of physico-chemical characterisation tests carried out in accordance with ISO 10993-18.

It concerns the identified extractable substances, whether organic or inorganic, that may come into contact with the patient during use of the medical device.

For each identified substance, a toxicological analysis is performed in accordance with the principles of ISO 10993-17.

MEDICAL DEVICE DEVELOPMENT SUPPORT

We offer you personalised support to define a biocompatibility strategy for the new device, including:

• Risk analysis
• Selection of relevant tests based on the characteristics of the device
• Literature search
• Toxicological assessment of substances
• Interpretation of results, with recommendations in case of non-compliancel'analyse des risques

OUR TOXICOLOGY SERVICES FOR COSMETIC PRODUCTS

SAFETY ASSESSMENT

We provide safety assessment services for ingredients and substances present in cosmetic formulations in accordance with Regulation (EC) No. 1223/2009.

Each ingredient is analysed individually, taking into account its overall characteristics as well as the substances it contains, particularly in the case of complex ingredients such as plant extracts, essential oils, or blends. The analysis also considers the target population for the cosmetic product, especially in specific cases such as sensitive skin, pregnant or breastfeeding women, or children under 3 years of age.

SAFETY REPORT

As part of the safety assessment, we offer the preparation of a structured report containing the elements detailed below. The client may choose to have the full report produced or only certain stages, depending on the project requirements. 

The CPSR (Cosmetic Product Safety Report), required under Regulation (EC) No. 1223/2009, consists of two parts: 

• Part A, which gathers the product’s safety data,
• and Part B, which contains the safety assessment.

A pre-assessment of Part B can be carried out, depending on the client’s needs, particularly for products intended for sensitive populations (for example, children under 3 years of age).

TOXICOLOGICAL PROFILE ANALYSIS FOR COSMETICS

As part of new product development, we offer solutions to optimise and ensure the safe selection of ingredients in cosmetic formulations:

• Collection and analysis of available safety data from the literature, along with the search for relevant toxicological reference values
• Predictive toxicological assessment using “read-across” concepts and the TTC (Threshold of Toxicological Concern) approach
• Analysis of the active principles of plant extracts, with a review of their potential toxicity based on scientific data, traditional uses, and known properties

SUPPORT AND ANALYSIS OF SAFETY TESTS

We assist you in selecting the most relevant safety tests based on your product’s characteristics, its method of application, and its target population (e.g., baby products, sensitive skin, pregnant women).
Our service also includes interpreting test results (skin tolerance, eye irritation, sensitisation, phototoxicity, etc.) and providing personalised recommendations to ensure regulatory compliance and safe use of the finished product. This support is particularly useful for guiding testing strategies within the framework of the safety dossier (CPSR), while avoiding unnecessary or unsuitable tests.