Industry & Service Providers

Consultants are a diverse group of actors that provide services to their clients, often SMEs which lack in-house expertise, around regulatory compliance. Regulatory support can include legal support for challenging regulatory agency decisions, assisting the compilation of regulatory dossiers and returns for clients, advising on regulatory compliance for clients and within the EU acting as an only representative.

Some consultants will offer general support services, whilst some larger consultancies will have specific experts to address different regulations or sectors. Often consultants will contract testing laboratories (CROs) for their clients and advise on which Test Guidelines are required.

Consultants do not have a formal role in the OECD Test Guideline (TG) development/revision process but can be part of expert groups. Their wide-ranging expertise is useful for providing advice to their clients' companies, industry associations and regulatory bodies. Consultants can be experienced users of TGs for their clients and also feedback on practical aspects of their use (e.g. on template proposed for results reporting). Consultants can also support TG or other supporting documents (e.g. Guidance Document) developments as contractors of National Coordinators or to the OECD itself.

For TG development, consultancies will often use their own funds to engage to offer their expertise to gain knowledge and to help introduce new TGs that they think will benefit their clients. For using TGs in regulatory compliance, consultancies will be paid by clients for specific projects and tasks.

There are a lot of consultants that provide services, for a checklist of how to find an appropriate regulatory consultant; see Consultant checklist (europa.eu).

Contract and Research Organisations (CROs) work on behalf of their clients to provide access to facilities and expertise, such as performing regulatory testing. They may also work on their own initiative in Test Guideline (TG) development, such as acting as experts. CROs have a wide variance in their structure. Some will be specialised in the areas they cover, whilst larger CROs may have different departments covering different areas. Most CROs will have a mixture of laboratory workers and support staff, including business development and marketing for securing new clients. Their engagement with TGs is likely to be working on regulatory testing on behalf of their customers and using relevant TGs to compile results needed for regulatory dossiers.

CROs play two main roles in Test Guideline (TG) development. Firstly, they work on using TGs for clients to perform testing for compliance with regulatory requirements. Secondly, they can contribute to the development of modified or new TGs in the areas in which they have direct experience. CROs often have a wide knowledge of requirements for modified or new TGs as they usually work for multiple clients, testing multiple materials against various regulatory requirements.CROs have a wide knowledge to draw upon and are usually able to comment on the challenges of the practical use of TGs from their own experiences of working with multiple clients. Some CROs will be interested in being engaged in modifying existing or developing new TGs where they know gaps exist, as this will help them develop their own knowledge and attract new clients. A CRO can contact their National Coordinator when interested in participating or commenting on an OECD project or contact the leading institutions indicated in the call for interlaboratory comparison within a project.

CROs will work directly for clients on performing testing on contract. They may also use their own funds to engage in developing new TGs (such as acting as experts). Some CROs will also work on funded projects related to TG development.

Examples of CROs can be found at EARTO | European Association of Research and Technology Organisations

SMEs are an important part of the wider industrial ecosystem. In Europe, around 99% of private companies are SMEs (companies employing less than 250 staff) in all sectors of the economy. The structure of SMEs can depend on their size, with smaller companies often not even divided into smaller units. Decision-making in SMEs can be simpler than in large companies and often decision makers can be easily identified. Many nano and advanced materials companies are SMEs.

SMEs, with the exception of those working directly on new methods relevant to regulations, are always not directly involved in TG development, although their input can be valuable. The interest of SMEs is sometimes represented by their relevant industry trade associations, which are part of the BIAC delegation, as SMEs often do not have the capacity to be regularly involved in TG development. SMEs are one of the main beneficiaries of TGs, although many will not directly use them themselves, but rather through regulatory consultants or contract laboratories that perform regulatory testing on their their behalf. SME input is useful to understand how they could use future TGs in their regulatory compliance. Also due to their small size and restricted ability to invest, SMEs can be good at identifying more efficient TGs to help them comply with regulations. SMEs can also be engaged through their representative bodies, such as relevant trade associations. Some SMEs will be more directly involved as they are developing new methods that could become future TGs.

SMEs can be funded in a variety of ways, including using their own funding for working on TG development. In the EU and countries where available, SMEs may also have project funding available to help them engage in TG development.

Large companies (i.e. those with more than 250 employees) include a wide range of often multi-national companies that produce a wide range of products and services. Some focus on particular market sectors, such as chemicals, whilst others will cover a wider range of market sectors. 

They are organised in many different ways. Often, they will have separate R&D, regulatory and production departments which can make understanding their interest in Test Guideline (TG)  development complex, as different units of the same organisation may be involved and may not always be aware of the participation of other units in other parts of the TG development process and use of TGs.

In the pre-OECD phase, large industries may suggest the development or the revision of Test Guidelines (TGs) or Guidance Documents (GDs) to their national coordinators or through their representatives at BIAC. At the project definition, and commenting phases at OECD, experts working for large industries may also directly participate in OECD committees, as part of a national delegation (e.g. WMPN) or as independent experts (e.g. expert group meeting). In addition to expert involvement, large companies may use their own laboratory facilities and staff for performing and supporting interlaboratory comparisons (ILCs) conducted during the project development phase at OECD. Finally, large companies usually use TGs for their regulatory compliance. Their input is useful in identifying discrepancies between available standards and regulatory frameworks.

Large companies will often fund their own involvement as experts or in attendance at OECD committees. They may also use their own laboratory facilities for performing and supporting ILCs. Occasionally companies may also access national or EU funding to aid their participation in relevant projects focussed on TG developments.

Industry associations are membership bodies based usually around a technology or sector and sometimes also with a geographical focus. Membership can be drawn from industry, service providers and research organisations, depending on the remit of the industry association. They engage with policymakers and other stakeholders on behalf of their members. Some industry associations (including CEFIC, ECETOC and the NIA) engage directly at OECD as part of the Business delegation at OECD (BIAC).

Some industry associations usually interact directly with the OECD Test Guidelines Programme as part of the BIAC Delegation. They are able to provide expertise and knowledge from their members and represent the needs and requirements of their members, predominantly industry. In the pre-OECD phase, industry associations may also be involved in funding projects that are developing new test methods. They often provide information to their members on the development, revision and use of TGs for regulatory compliance. Industry associations can also be project leads, usually for Test Guidelines or Guidance Documents developed by their members.

Industry associations will either use their own funding from membership fees to contribute to the Test Guideline development process or will use project funding, such as EU funding.

A list of affiliated companies and national associations appointing their staff to Business at OECD policy groups can be found here: Our global network | Business at OECD.