Services
Inter Scientific provides regulatory consultancy and analytical testing supporting pharmaceutical, CBD, nicotine and medical device clients. Our bespoke services are designed to offer a single point solution for your needs, so your products can be marketed safely and legally.
Whether you’re a one-person start-up or a multinational organization, mapping the regulatory landscape can be challenging and costly. Our experts will assist you at every stage of the product life-cycle, from product development through to post-launch activities.
Regulatory Process Flow
Importing or manufacturing a regulated product comes with a great deal of responsibility and often involves complex systems and processes to be in place to ensure compliance, including the requirement of a Quality Management System.
Inter Scientific is uniquely positioned to assist in 360° of the product life-cycle process, and we can help with as many or a few of the stages required. Whether supporting our clients to implement processes and procedures through in-house consultancy or managing their regulatory processes on their behalf, we aim to create innovative solutions for theirs and their products needs.
- IdeationIdeation is the first step of the regulatory process life-cycle. Here, the idea is born this may be from a moment of inspiration or from a planned, systematic process. Our experienced teams can help guide the ideation process in steering ideas through the identification of current market challenges or consumer needs
- Concept RefinementThe ideation step can throw out a lot of ideas, some of which may be potential blockbusters and others fit for the dumpster. Refining strong ideas is a key stage of stress-testing and ensuring freedom-to-operate, safety, and compliance potential
- Concept TestingTesting concepts both chemically and with potential consumers give useful insights into product performance and safety. Preliminary laboratory testing can help in the re-design and further concept refinement before significant capital is placed into projects
- Dossier GenerationThis is a process of compiling all the required information on the product safety and quality, from lab testing, electronics testing, or from risk assessments. The purpose of any regulatory dossier is to convey, in a systematic approach, the information relating to a particular product. For complex projects, such as pharmaceuticals, novel foods, and premarket tobacco applications, such dossiers require a multitude of expertise and competence to draw the information together.
- Compliance TestingProducts should be tested for compliance against pre-existing standards and regulatory requirements. For many cutting-edge developments, however, established test methodology may not exist. Testing products to ensure their safety and quality is a core element of regulatory compliance and the results underpin many regulatory dossiers. Furthermore, where not regulatory dossier is required, company diligence in ensuring product safety is a legal requirement under Tort
- Regulatory EngagementEarly engagement with regulatory authorities can be pivotal in getting a product to market fast. Regulatory engagement is a process of communication and education ensuring the right level of information is communicated and product particulars are understood by the regulatory authorities. Through this process, a rapport is built with the regulator, and the regulatory strategy, including testing strategy, can be refined and agreed
- Regulatory SubmissionThe format, presentation, and submission of a regulatory dossier is often governed by complex rules set by the regulator. Once submitted, dossiers may undergo a comprehensive review with a period of time for regulatory authorities to ask further questions or require further information. This process is often well established (pharmaceutical, PMTA, and novel foods) and timely response to queries is key in ensuring speed to market
- Postmarketing SurveillanceFor information that cannot be generated at the point of submission, for example, where products require approval before the product can be placed on the market and therefore consumer-related data is not available, post-marketing commitments may be made. This is typically done to ensure that any risk-based assumptions made at the point of submission were accurate. Further, manufacturers/importers are often required to proactively monitor their product on the market for risk (e.g. product defects or safety-related reports). These data help regulatory authorities balance the risk: benefit of a particular product
- Corrective Actions & RecallIn the unlikely event that a product, when placed on the market poses an unacceptable risk to the consumer or to public health, a product recall may be required under extreme circumstances. Having a defined process for product recalls including the ability to disseminate the recall notice can save a company an intangible amount in both reputation and litigation. Where a defect is identified that is not severed or does not pose a significant risk, corrective action may be implemented including field safety corrective action (FSCA)
The Tobacco Products Directive (2014/40/EU) is the European Directive governing the manufacture, importation and sale of tobacco products with the European Union. The Directive covers cigarettes, oral tobacco, novel tobacco products and e-cigarettes & e-liquids (ENDS). The Directive came into legal effect in May 2016.
In May 2016, the Food and Drug Administration finalised its “deeming” rule, subjecting nicotine products to scrutiny under the Federal Food, Drug, and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. Products marketed after February 2007 must submit a Premarket Tobacco Product Application (PMTA) before the product can be sold in the US.
Since January 2019, CBD products have been regulated as Novel Food Products in the European Union following the decision by the European Commission. CBD manufacturers, trade bodies and suppliers are required to apply for authorisation with a deadline of March 31, 2021 set for all applications for products on the market.
Pharmaceuticals and medical devices are highly regulated with comprehensive requirements to ensure patient safety and product quality and efficacy. Inter Scientific brings all the required skills together to offer our clients state-of-the-art knowledge to decrease the regulatory burden.
We also offer bespoke scientific consultancy services. Contact us to learn more about how we can help
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