Regulatory Affairs

We can support on your projects all along the lifecycle of the products to ensure compliance withe the regulatory requirements and timely approval in a worldwide range.

Regulatory affairs

Regulatory affairs is the domain that monitors the way food, drugs, cosmetic products, medical devices are developed, tested, manufactured, marketed and distributed in order to certify that they meet regulatory standards for human and animal use.

Regulatory Affairs plays a crucial role in the health products industry from the early developpement phases throughout the life cycle of the health products, where they are responsible ensuring manufacturer’s compliance with applicable laws and regulations as well the safety and efficacy of health products.

We can support on your projects all along the lifecycle of the products to ensure compliance withe the regulatory requirements and timely approval in a worldwide range. Our team ensure a close partnership to provide a personalised offer in accordance with regulatory requirements and in compliance with your processes.

Our expert teams have over 25 years of regulatory knowledge and experience in global level to viable strategies and efficient development pathways thanks to 3 key advantages:

Full industry scope

We are specialised in all facets of pharmaceutical and medical device development and regulation.

FDA, EMA and International

We combine extensive scientific and regulatory experience to achieve successful outcomes with regulators across continents

Full life cycle support

From early-stage development through to approval and marketing, our regulatroy affair consultants supports our clients to meet regulatory needs across the entire life cycle of products

Solutions by Industry

Pharmaceutical, Biotech and Vaccines

We are able to support our clients on the overall regulatory activity’s initial submission and life cycle management (Renewals/ administrative, quality and safety variations), MAH extensions, MAH withdrawals) on EU, US and all International regions, in compliance to the regulatory requirements and in respect to the timelines and strategies defined. A non exhaustive list of activities is provided herafter.

Pre-Marketing Authorisation:

Regulatory intelligence, strategies and advices within all regions
Due diligence and compliance
Scientific advice and agency consultation management
Regulatory Project Management and Follow up from the beginnig to the approval of the project
Market access
Clinical Trial Applications
Authoring of IND/IMPD dossier
Authoring of complete or update of Modules 1-5 as applicable to your products
Authoring of complete or update and submission of CEP, ASMF
Responses to Questions of the Competents Authorities
Create or update, review and validation of initial labelling, Art-works, CCDS, CCSI, SmPC, PIL and other related documents
Management of Renewals
Management of Variations (administrative, quality and safety)
Advertising and promotional materials: Create, review, validate and submit to health authorities all advertising and promotional materials
Annual Product Review
Management of Change controls
Dossier Management, publishing and submissions
Infomed

Medical Devices

We support our clients on the overall activities for the Registration of medical devices in Europe, US and Internatial Regions in order to place in the market medical device as fast as possible and in compliance to the regulatroy requirements. A non exaustive list of acitivites is provided herafter:

Regulatory intelligence, strategies and advices within all regions
Due diligence and compliance
Classification of the Medical Devices
Definition of the list of documents, tests, studies to be provided in compliance with the regulatory regquirements
MDR & IVDR technical file remediation and compilation (EU 2017/745) & (EU 2017/746) and CE marking and maintance
Quality Management system in accordance with ISO 13485
Risk Management support
Management of Risk Analysis / Risk assesssments
Management of complete or update technical file
Management and writing of PSURs / PMS / PMCF / PMPF
Management and writing BER
Management and writing of CER – PER / CEP – PEP
Support on Labeling, Advertising and Promotional materials
Support on Notified bodies Audits
510(k) submission
Support on MDSAP Audits
Internal Audits

Veterinary

We support our clients on the overall regulatory activity’s initial submission and life cycle management (Renewals/ administrative, quality and safety variations), MAH extensions, MAH withdrawals) on EU, US and all International regions, in compliance to the regulatory requirements and in respect to the timelines and strategies defind for the veterary medicines. A non exhaustive list of activities is provided herafter:

Pre-Marketing Authorisation:

Regulatory intelligence, strategies and advices within all regions
Due diligence and compliance
Regulatory Project Management and Follow up from the beginnig to the approval of the project
Market access
Authoring of complete or update of Part I – IV as applicable to your products
Authoring of complete or update and submission of CEP, ASMF where applicable
Responses to Questions of the Competents Authorities
Create or update, review and validation of initial labelling, Art-works, PIL and other related documents
Management of Renewals
Management of Variations (administrative, quality and safety)
Advertising and promotional materials: Create, review, validate and submit to health authorities all advertising and promotional materials
Annual Product Review
Management of Change controls
Dossier Management, publishing and submissions

Food

We support our clients on the overall regulatory activity’s initial submission and life cycle management on EU, US and all International regions, in compliance to the regulatory requirements and in respect to the timelines and strategies defind for the food supplements.

Regulatory Intelligence, strategies and advices
Analyses of Regulatoray Requirement
Defintion of stategies in fonction to the project
Definition of the list of documents, tests, studies to be available in compliance with the regulatory regquirements
Writing or update of the technical file
Validation of the claims and Labeling, in compliance to the regulatory requirements
Preparation of the notification/registration dossier in compliance to the local regulatory requirements
Notification / Submission to the competent authorities
Follow up and update of the dossier as necessary

Cosmetic

We support our clients in a full range of Regulatory activities for the Notification and Registration of their Cosmetic Products in EU countries and International Regions.

Regulatory intelligence, strategies and advices within all regions
Validation and analysis of the qualitative and quantitative ingredients in the formualition
Definition of the list of documents, tests, studies to be available in compliance with the regulatory requirements
Definition of stategies in fonction to the project and validate with the client
Writing PIF Part A
Writing PIF Part B -toxicological expertise
Validation of the claims and Labeling, in compliance to the regulatory requirements
Preparation of the notification/registration dossier in compliance to the local regulatory requirements
Notification CPNP
Follow up and update of the dossier as necessary

We provide regulatory solutions and assistance throughout the life cycle of drug products, medical devices, cosmetic products and food supplements (pre-MA and post-MA activities). Our teams ensure a close partnership to offer a personalised response in accordance with regulatory requirements and in compliance with your processes.

Merita, regulatory affairs expert

Our delivery methods

Technical assistance
Technical support, advice and expertise

Platform
A range of services dedicated to your activities driven by our team

Projects
Perfomance with commitment to results

Aixial Group around the world

Aixial Group can help you around the world. We provide services onshore, nearshore, and offshore to ensure that your solution is customized to your specific needs.

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