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Regulatory framework analysis

Regulatory framework Agency Consulting firm Experts Specialists Consultancy

Understand the regulations and anticipate potential regulatory changes

For more than 30 years, our specialized team has been supporting companies in performing regulatory framework analysis related to their activities in order to define the positioning of their products or services on the market.

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    Key success factors for a regulatory framework analysis

    Launching a new product or service requires an in-depth analysis of market access conditions, including an inventory of the legal constraints (authorizations, approvals, certifications, etc.) that define what can and cannot be done. Given that the regulatory framework is constantly evolving, it is essential to be prepared for changes. Changes in legislation, in your target markets, and to prevent threats and anticipate opportunities.

    Because regulations evolve and differ from one country to another, it is vital to define the scope of the product or technology whose regulation is being studied. This involves understanding the boundaries around a product to identify which regulations apply to it and which do not.

    To which regulatory texts does my product refer? To which category does the product or technology belong? Do the regulations clearly define the product?

    Understanding previous changes to the regulations governing a product or service means not only knowing about them, but also identifying the factors or events that triggered these changes. Also, by analyzing the major current issues and the regulatory discussions underway, we can imagine possible future changes, which will need to be anticipated in the development of products/services.

    What are the previous authorizations and what were the associated constraints? What event could lead to a change in regulations? In what direction might the regulations evolve?

    To ensure that the regulatory analysis carried out has an impact, the consequences of these regulations need to be analyzed. In this way, regulatory analysis can lead to an assessment of the risks and opportunities for a sector, a market, a product or a service. A regulatory analysis approach makes it possible to anticipate future steps to be taken as part of an innovation process (e.g. applying for marketing authorization).

    What impact will regulations have on my own business, that of my suppliers or that of my customers? How can I use regulation as a lever for differentiation and competitiveness?

    How we support you in your regulatory framework analysis

    Alcimed assists its clients in analyzing the regulations related to their activities. The launch of a new product or a new service requires an in-depth analysis of market access conditions, including an inventory of the legal constraints (authorizations, approvals, certifications, etc.) that define what can or cannot be done.

    As the regulatory framework is constantly evolving, Alcimed also helps its clients prepare for changes in the current legislation in their markets, in order to prevent threats and anticipate opportunities.

    What they say

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      Philip HO

      Global Vaccines Public Affairs

    Examples of regulatory framework analysis carried out for our clients

    • Regulatory framework analysis of the accessibility of orphan drugs

      We supported a pharmaceutical industry player in understanding the fundamental factors of market access for orphan drugs in 9 emerging countries.

      Through an internal review of the current state of knowledge, then collecting missing information in terms of market and regulatory framework analysis in particular, Alcimed enabled its client to obtain an overview of orphan drug regulations in emerging countries and to classify these countries according to their level of accessibility.

    • Regulatory framework analysis of the development of new cannabis/CBD-based products

      We helped the R&D team of a leading food and beverage company to understand the current legislation regarding the use of CBD and cannabis in food and beverages, with the aim of developing new products for the European and North American markets.

      After a first step of exploring the target markets (trends, existing products on the market, health claims, legislative framework, etc.) we characterized the regulations (current or future) in a selection of countries through an in-depth literature analysis and targeted interviews (regulators, experts).

      This work enabled our client’s R&D team to define a framework for the development of new CBD-based products.

    • Regulatory overview of greenhouse gas emissions regulations

      One of our clients, an automotive industry player, wanted to carry out a review of the regulations on greenhouse gas emissions in Europe and gather the view of car manufacturers on related trends.

      The inventory of the regulations and standards in force, the analysis of their dynamics, as well as the variation of these regulations in France and the point of view of the car manufacturers helped our client to prepare technical solutions to be implemented in order to anticipate changes in regulations.

    • Regulatory decipher : market access strategy for syringes in China

      One of our clients, a leading player in the medical device industry, wanted to enter the Chinese market and needed to understand the Chinese market specifications and potential in order to develop a clear growth strategy and evaluate the resources needed to achieve its development ambition in the area.

      One of the key points required by our client for our study was to understand the local regulations in order to comply with the Chinese specificities. Our team first conducted a detailed analysis of the competition in place, before exploring the current practices, needs and expectations of potential syringe buyers and users. Following this first investigation, we then deciphered the regulations and the impact of local cultural specificities on the market access of our client’s products.

      This exploration work allowed us to recommend to our client the best strategy to undertake in order to set up in China and become a future leader in this new market.

    • Analysis of the regulatory framework for over-the-counter medicines for a dermo-cosmetics player

      For a major player in dermo-cosmetic products, Alcimed carried out a regulatory analysis of over-the-counter medicines.

      We carried out an in-depth study of the regulations surrounding OTC medicines and the various authorisations required to market such products. In the geographical areas under consideration – Europe, the United Kingdom, the United States and Canada – a study of the literature and interviews with regulatory experts and OTC manufacturers enabled us to decipher the marketing processes, the key components of authorisation dossiers and the pitfalls to be avoided.

      Thanks to this work, we have highlighted the steps to follow, in particular the applications required and authorisations to be obtained in each of these geographies for a given type of product, making it possible to refine the Go-to-Market strategy.

    • Study of the regulatory framework surrounding sugar restrictions for a leading agri-food company

      For a major player in the food industry specialising in ingredients containing simple and complex sugars, Alcimed has produced an overview of the regulations governing the use and marketing of sugars in several regions (Europe, North America, South America and Asia).

      Working with the regulatory teams in each geography, we highlighted the differences and similarities between them.

      Our study enabled our client to anticipate regulatory changes in its market, whether these regulations impacted it directly as an ingredient supplier or indirectly by affecting its customers in the food industry.

    You have a project?

      Tell us about your uncharted territory

      You have a project and want to discuss it with our explorers, write us!

      One of our explorers will contact you shortly.


      To go further

      Founded in 1993, Alcimed is an innovation and new business consulting firm, specializing in innovation driven sectors: life sciences (healthcare, biotech, agrifood), energy, environment, mobility, chemicals, materials, cosmetics, aeronautics, space and defence.

      Our purpose? Helping both private and public decision-makers explore and develop their uncharted territories: new technologies, new offers, new geographies, possible futures, and new ways to innovate.

      Located across eight offices around the world (France, Europe, Singapore and the United States), our team is made up of 220 highly-qualified, multicultural and passionate explorers, with a blended science/technology and business culture.

      Our dream? To build a team of 1,000 explorers, to design tomorrow’s world hand in hand with our clients.

      A regulatory framework analysis is a study of the regulatory texts in force in a given context to serve a precise objective, such as defining the legislation applicable to a product in a target market.

      A regulatory watch is a constant study of changes in current legislation, with the aim of anticipating changes in a given context and ensuring compliance with regulations, or even detecting upstream opportunities linked to changes in legislation.

      Regulatory analysis can make sense, for example, when developing a product or service, or more generally when bringing an innovation to market. Its aim is to anticipate regulatory requirements, the necessary applications for authorisation, the regulatory constraints to be met, and to identify possible regulatory differences between countries in order to validate product and service launch strategies.