The Brexit Transition Deadline and Its Impact on the Life Sciences Industry
On January 1, 2021, the Brexit transition deadline between the UK and the EU came into effect, causing concerns among manufacturers aiming at EU/UK market-entry. Despite continuous updates regarding regulatory modifications in the regions, many companies remain worried about their ability to remain compliant. Templarpharma, with its proven track record in the EU and UK markets, is providing exclusive Brexit-related regulatory support to life sciences, biotech, and med-tech manufacturers.
End-to-End Compliance Support
To ensure end-to-end compliance in the Brexit scenario, regulatory team provides support to all aspects of regulatory affairs, pharmacovigilance, and compliance. Our team is working tirelessly around the clock to ensure that all possible scenarios are mapped and that all possible outcomes are compliant enough for successful market entry. With our expertise and preparedness, we help our clients navigate through the complex regulatory landscape to meet their goals.
Expertise in EU and UK Markets
As a trusted regulatory partner, has extensive experience working in both the EU and UK markets, providing a deep understanding of the regulatory requirements and updates in these regions. Our team has successfully assisted numerous life sciences companies with EU and UK market-entry and regulatory compliance, enabling them to achieve their business objectives.
Proven Track Record
Has a proven track record of helping life sciences companies overcome regulatory challenges, including those posed by Brexit. Our regulatory experts have a deep understanding of the regulatory landscape and stay up-to-date on the latest developments, enabling us to provide effective support to our clients. Our clients can trust us to provide timely and compliant solutions to meet their needs in the rapidly changing regulatory environment.
Expertise in Brexit-related Regulatory Support
Regulatory Software and Services
These companies offers a wide range of regulatory software and services to ensure compliance with various regulations. Our regulatory software solutions include SUBMIT PRO. Which supports eCTD publishing and submissions, LABEL 360, which caters to the end-to-end lifecycle of labeling, and iREADY, which tracks, analyzes, and validates cosmetic ingredients against new norms and deals with any Brexit terms. We also provide a centralized and collaborative approach to data management and enhanced automated product lifecycle management to empower robust and cloud-hosted software applications.
In addition to software solutions, These companies offers regulatory services to assist with compliance, such as updating chemical and biocide dossiers and notifications, supply chain regulatory compliance review/assessment, and technology in Brexit-related regulatory support.
Health Authority Interaction
Navigating health authority interactions can be a complex and challenging process. But These companies is here to assist with our regulatory expertise. We provide regulatory consultation to assist with regulatory strategy, regulatory intelligence, and regulatory labeling. As well as regulatory publishing and submissions. We also offer in-country representation/legal representative services and MDR registration and submission assistance to global health authorities.
These companies provides comprehensive regulatory support for medical devices. Including developing a clear MDR implementation strategy and end-to-end support to develop clinical evaluation reports (CER) including literature search as per European Medical Device Regulation (EU MDR) guidelines. We also offer services for MDR registration and submission assistance to global health authorities. Regulatory intelligence about the importation process of various regulated markets.
Food and Food Supplements
Regulatory changes in the food and food supplement industry can be daunting, but These companies is here to help. We offer regulatory assistance to help you keep up to date on impending regulatory changes and to assist you through the transition. We also provide regulatory assistance for mandatory amendments to food/food supplement labels and import/export licenses as per the changes.
Chemicals and Biocides
These companies offers regulatory strategic support for transitioning. As well as regulatory compliance support for new UK regulations in the areas of chemicals, cosmetics, and biocidal products (UK-BPR). Our services include updating chemical and biocide dossiers and notifications and supply chain regulatory compliance review/assessment.
Technology in Brexit-related Regulatory Support
Brexit has brought significant changes to the regulatory landscape. And These companies is here to assist with technology in Brexit-related regulatory support. Our services include software data migration strategies inclusive of resource allocation to implement and technological support. As well as unifying processes to a single source of truth of RIMS (Regulatory Information Management System).
These companies provides a comprehensive range of regulatory services. Software solutions to help clients navigate the complex and ever-changing regulatory landscape. Our expertise includes medicinal products and regulatory support, EU/UK market analysis. Market access and regulatory strategy, safety and pharmacovigilance, and much more. Contact us today to see how we can assist you with your regulatory needs.