REGULATORY AFFAIRS EXPERTS
Pen & Tec provide the link between science, regulatory compliance and reaching commercial goals by helping companies worldwide to sell their products on a sound legal basis. We have the best technical knowledge to help you successfully register your product in the selected target market, in the fastest time possible.
PROFESSIONAL ADVICE WHEN YOU NEED IT
We offer advice and support at all levels and stages of registration projects, from initial planning and budgeting, through to designing and monitoring studies, reviewing data and preparing scientific dossiers for submission. Our creative approaches can save significant amounts of time, and offer fast-track alternative routes to market, where these are available.
Alternatively, our team can also advise on applications that have run into trouble with regulators, as well as provide options for broadening the usage of a product or manage renewals as existing approvals expire. We are also experienced in providing key advice on labelling and claims, allowing clients to exploit marketing opportunities within legal boundaries.
WORKING WITH INTERNAL REGULATORY TEAMS
We work with clients to define optimum regulatory strategies, and help deliver selected solutions within agreed time frames. Our managers are equipped to support client regulatory teams when time and internal resources are in short supply. We can review scientific and regulatory documents before submission to the relevant authorities, identify gaps and anticipate potential pitfalls. We can also deliver training targeted to individual needs and expert advice at any stage of your project.
We help bridge the gap between commercial and regulatory departments so that senior managers can meet business objectives. We not only provide advice on the data required to build a technical dossier, but can also help you justify which data could be omitted, or provide strategic options to reduce delays in the registration process.