FROM R&D TO PRODUCT APPROVAL
Pen & Tec have years of experience helping clients to move their product from the early stages of R&D to market approval. Our experienced team can advise you on the regulatory requirements needed to place a product on the market by helping you to choose the right regulatory pathway, identifying gaps in the data and guiding you to build a compliant body of evidence to support the safety and in some cases, the efficacy of your product.
BENEFITS OF CHOOSING THE RIGHT REGULATORY STRATEGY
Choosing the most effective regulatory pathway for your product can save you time and money and ensures that your product fulfills its full marketing potential. For certain products (i.e. genetically modified microorganism (GMM)), the legislation and guidance documents are complex, meaning that the interpretation of what is expected by the authorities can be misinterpreted and can lead to vital information being missed out or overlooked.
We can help you identify the key data necessary for the registration of innovative products, and advise on the impact of data requirements when registering a product that is a GMM, qualified presumption of safety (QPS), highly purified or with many identified impurities, ensuring that all data requirements are met, which can speed up the evaluation process.
Our team can also assist with study design, protocol and reporting requirements, as designing compliant studies based on the latest guidance and legislation will reduce questions from the authorities during the evaluation process & prevent unnecessary delays.
REDUCING UNNECESSARY DELAYS
We have been advising clients on regulatory affairs for over 20 years, working in close contact with the European Food Safety Authority (EFSA) since its creation in 2002. Our in-depth knowledge of EFSA requirements and working procedures enable us to provide expert advice and strategic options to prevent delays in the evaluation process.
For best results, we work with clients during the early stages of product development to identify the correct legal status and fastest route to market. We can also act as project managers to help avoid errors that slow down time to market.
MULTILINGUAL SCIENTISTS SPECIALISING IN REGULATORY AFFAIRS
Our multilingual team of life scientists are specialists in food chain legislation. All regulatory managers are equipped with the best background to help bridge the gap between R&D, marketing objectives and regulatory compliance in order to take a product to market as quickly as possible.