Life Sciences Regulatory & Compliance

Spend Transparency Reporting

Transparency in the relationship between life science companies and healthcare professionals (HCPs) as well as organisations (HCOs) has become significantly crucial to the reputation and credibility of pharmaceutical companies globally – irrespective of but simultaneously supported by spreading country-specific legislative or regulatory pressures. The legislative framework worldwide is growing constantly, geographically and in complexity and pose new risks of missing compliance deadlines, compromising company reputation and fines associated with incorrect information reported. PwC has created services that address the implementation and monitoring of transparency, the rules of which have been in force for some years that could help your company to effectively manage a worldwide transparency program.

Our solution to simplify and deliver 100% of transparency reporting

Automated end-to-end transparency reporting

Transparency Hub is a true all-in-one, cloud-based solution for global transparency reporting. Built by experienced professionals, it speeds and simplifies reporting.

Transparency approach will move your business forward as you will
Reduce Compliance & Reputational Risks: Meet all the requirements and deadlines in transparency reporting and compliance. Increase your reputation and strengthen your competitive position as a more respectable and trusted company.
Increase Efficiency: Constantly update to the latest status, trends, changes and new requirements set by European standards. Ensure data completeness and quality.
Employ State-of-the-Art Analytics & New Insights: Covering cross-border activities to expand in other countries and markets. Improvements and recommendations for data processing and analytics in marketing, business and finance.

Different models can be offered to help companies achieve their disclosure targets. Based on client’s requirements, the extent of services can comprise

Detection and Monitoring Hub, a PwC Product, identifies compliance insights, target high-risk activities in rapidly changing markets and better allocate your resources accordingly through the application of advanced analytics and machine learning.
Additionally, data gathered for reporting can be further utilized and analyzed exceeding the compliance purposes. Get more information about our Data & Automation capabilities here.

Regulatory Support Services

IDMP

Identification of Medical Product (IDMP) is a significant data standardisation challenge for pharmaceutical companies, aiming at a unique identification of medicinal products. European Medicines Agency (EMA) is the first of those who decided to mandatorily adopt these new ISO standards. Meaning that after a regional deadline (expected in 2022-2023), all pharmaceutical companies operating in the European Union must comply with IDMP regulations. Other regions (including the United States and Japan) are expected to provide their deadlines gradually. Although timelines for IDMP implementation have been shifted, it is inevitably coming to the final stage as EMA released version 2.0 of the EU IDMP Implementation Guide (EU IG v2.0) in February 2021, disclosing more details on how to proceed with compliance preparations. For those who have not launched their IDMP projects yet, or are at the initial stage, this is the right time to mobilise. Staying idle is not an option.

We support our clients in their efforts to unlock the power of product data thanks to IDMP, and transform their business and improve patient health by:

Support of Registration Management

We understand that the regulatory environment is complex enough, and we are continuously striving to find solutions for the purposes of simplification and effectiveness. Registration-related fees have a significant impact on the planning and financial lifecycle of each product.

We can help you to:

• Consolidate input from different regulatory sources across countries to ensure their up-to-date overview and reduce manual workload;
• Monitor & maintain the whole regulatory budget so you can quickly react to changes;
• Easily explore & compare options to determine the most suitable registration strategy.

Requirements that registration documents are of a higher quality are increasing, and thus companies should thoroughly deal with deficiency letters from regulators in order to minimise prolonging timelines or to avoid withdrawal of registration.

We can help you to:

• Forward all deficiencies received or comments from regulatory authorities to a database and to utilise the lessons learned to become more efficient;
• Connect to a powerful analytical tool to perform evaluations and generate customised visualisations and dashboards providing meaningful insights.

Business Support Services

Strategic Visioning

We partner with our clients to strategically envision the future of their regulatory & compliance activities. Defining the difference between the current state and the desired future state is the first step in planning a successful program enhancement initiative. After performing a discovery exercise, PwC can develop a project roadmap to achieve the client’s goals.

Process Optimization & Operational Support

PwC’s Process Optimisation & Operational Support helps you achieve your business objectives by fulfilling key talent gaps and delivering global support. PwC can provide a deep pool of global, industry-dedicated service delivery resources with a strong understanding of local laws and requirements, and requisite language capabilities. Our industry-dedicated teams and service delivery centres are equipped to support your specific program needs.

Data Analytics

As an integral part of our services we provide our clients with solutions employing powerful analytical tools to optimise their data assets and maximise output of their data which enable faster and better decisions. To get more information about Data&Automation, click here.

❮ ❯

Tax & Legal Services

The pharmaceuticals industry in the Czech Republic is characterised by a high degree of foreign ownership. Pharmaceuticals companies operating in the Czech Republic are subject to an extremely strict and complex regulatory environment. The Czech State Institute for Drug Control (Státní ústav pro kontrolu léčiv) regulates every aspect of business, from pricing to packaging, from clinical trials to advertising.

PwC' pharmaceuticals experts are among the top specialists in the country and can provide sound advice with regards to the tax, legal, and regulatory issues affecting this industry.

Industry issues

Industry-specific services