Consulting, Training & Outsourcing

Regulatory compliance and assessment is increasingly complex when marketing in multiple product categories in multiple countries/regions. Sustaining high-quality regulatory expertise in house can be challenging, and the negative commercial impact of noncompliance can be severe.

As an alternative to building and maintaining this expertise stand-alone and internally, TRC offers custom options in the form of training, consultancy and outsourcing to match your needs for ad hoc or continuous regulatory support.

type of support

Consulting, Training, Outsourcing

product scope

Cosmetics, personal care

Markets covered

EU, UK, US, Canada

engagement

Ad-hoc or continuous

— consultancy services —

Strategic guidance by senior regulatory & safety experts

While having internal regulatory and safety expertise in house, you may run into “one-time-only” cases, decisions or need for strategic direction where day-to-day knowledge is not sufficient. These could for example concern:

Categorization of products and its implications, benefits and drawbacks from a regulatory perspective
The set-up of an adverse events/cosmetovigilance programme
Authority inspection and re-call issues
product testing strategies and second opinions
Supplier and manufacturer qualification
How to manage Product Information Files for complex product portfolios

Our senior experts have up-to-date working experience on highly diverse products in diverse product categories, and individually have up to 30+ years of experience working with SMEs and globally operating companies.

As a team, we pride ourselves in going the extra mile to resolve whatever case you have in front of you, supporting your internal regulatory team to move forward, and (temporarily) taking outsourced regulatory roles and performing tasks as an external extension of your team.

— TRaining services

Training services, according to your specific business needs

For all those conducting business in the cosmetics industry, it is important to have a basic understanding of the applicable Regulations. Having a basic understanding will enable you to take the right decisions along the way from a regulatory compliance and safety perspective, for example while selecting your suppliers, formulating your products and positioning, marketing and making claims about your products.

Companies committed to managing the regulatory compliance and safety internally seek to deepen knowledge on a specific aspect or gain broader knowledge on related regulatory topics from time-to-time. Sourcing this knowledge externally through training will help to grow and maintain internal expertise.

TRC has extensive experience with in-company trainings of regulatory departments, participation in academic and professional courses, and long-term training of (inspection) authorities. The topics covered can range from introductions to the applicable regulations, the compliance process, how to structure and organise regulatory team to very specific topics such as borderline product classification, claim substantiation, testing requirements, and much more.

— Outsourcing services —

Outsourcing

For companies that take the perspective to focus on their core competences and/or have limited capacity to build and maintain regulatory experience, it is beneficial to source regulatory expertise outside of the company. Outsourcing to the right partner will ensure continuity, high-quality and maximum protection of commercial interests.

In the longer-term, a knowledgeable well-organised partner will assist you in the setup of robust processes to prevent wrong decisions in choosing your suppliers, formulations and manufacturers to save time, resources and costs for unnecessary rework.

For most of our customers we provide all-in full regulatory services. A number of our current customers have requested us to take our services a step further and to actively participate in internal processes and/or meetings.

Outsourcing (part of) the regulatory work can be shaped according to your needs, for example: by (part-time) heading the regulatory team; coordinating (nano) cosmetic ingredient research and registration; or completely taking over the regulatory function.

— The TRC method

Compliant in 5 steps.

Our structured compliance process removes complexity and creates a clear, easy pathway to market – in every jurisdiction, powered by PRIMS Compliance and Safety Software in every step.

The process aligns with the requirements of the regulations and includes all the prerequisite services needed for compliance and safety as needed for your portfolio: