European Lifecycle Management

Regulatory Product Launch

Optimizing the value of a medicine from a regulatory perspective is a multifaceted endeavor, which necessitates meticulous planning. Each country or region has unique regulatory requirements, healthcare systems, and market dynamics. In this context, a robust post-approval launch strategy plays a pivotal role in ensuring a successful post-approval product launch. Local regulatory launch plans are essential for navigating country-specific intricacies, ensuring compliance, and optimizing market access.

Our Regulatory Product Launch Consulting Support Includes: 

• Project management; multi-country
• Product launch checklists
• Review of artwork for printing
• Registration in local regulatory databases
• Publication of product information in local catalogue texts
• Registration with local serialization verification organizations
• Advice on specific local country regulatory requirements

European Regulatory Lifecycle Management

After your initial application has received marketing approval from the regulators, you need to remain compliant with all regulatory requirements needed to keep your product on the market. A strategic approach to lifecycle management is necessary to maximize the potential of your product.

Regulatory Project Management

In the dynamic landscape of pharmaceuticals, regulatory compliance is paramount. From drug development to market approval and commercialization, every step requires meticulous planning, coordination, and adherence to global standards. This is where Regulatory Project Management steps in as a critical function.

The Role of a Regulatory Project Manager in the Pharmaceutical Product Lifecycle

Our Regulatory Project Management Consulting Support Includes:

• Expert team of Regulatory Project Management consultants with extensive experience combining scientific, regulatory, and business knowledge to ensure products that are developed, manufactured, or distributed meet regulators’ expectations at regional, national, and local levels
• RPM coordination of all European Regulatory activities (Regulatory submission strategy, multi-country Product Launch, Product Lifecycle Management, Regulatory Intelligence, and Promotional Materials Review)
• End-to-end planning, coordination, and execution of regulatory procedures and submissions
• Delivery through proactive and open communication, effective project planning, stakeholder management, leading cross-functional teams, communication planning, risk mitigation, and issues resolution

Regulatory Intelligence

In the ever-changing regulatory landscape, staying informed of applicable regulatory requirements is crucial. Regulatory Intelligence involves systematically gathering and analyzing publicly available information related to regulations. Monitoring regulatory changes demands seasoned expertise and our team brings years of experience, providing you with actionable insights that empower your compliance efforts.

Our Regulatory Intelligence Consulting Services Include:

• Global and local Regulatory Intelligence support
• Strategic advice on national legislation and specific requirements
• Monitoring evolving information and responding to changes in the regulatory landscape
• Identifying, integrating, and analyzing regulatory information
• Reporting according to customer requirements

Review of Promotional Materials

In the life sciences industry, reviewing promotional materials is not just a formality; it’s a critical step in ensuring compliance, patient safety, and brand reputation. Promotional materials must adhere to strict local regulations and deviations can lead to penalties, product recalls, or legal consequences. Rigorous review ensures that claims are evidence-based and do not misrepresent the product’s benefits or risks. Promotional materials directly impact how healthcare professionals and patients perceive a product. A well-reviewed campaign enhances trust, while errors can tarnish the brand's image.

Outsourced Regulatory Affairs Functions

In today’s dynamic business landscape, organizations face increasing regulatory complexities. Navigating global and local regulations demands expertise, resources, and strategic planning. We recognize that each client is unique and adapt our service offering according to our clients’ needs. Outsourcing regulatory functions can be a strategic move to optimize efficiency, enhance compliance, and focus on core business objectives. Whether you’re a multinational corporation or a local player, understanding the benefits and considerations of outsourcing your regulatory affairs obligations is crucial. At ProPharma, we don’t just manage projects; we drive them forward. With our unwavering commitment to oversight, strategic thinking, and client engagement, we’re your trusted partner in achieving regulatory success.

Outsourcing all or part(s) of your regulatory affairs department to ProPharma’s team of Regulatory Sciences experts provides access to a pool of seasoned professionals.

• Our regulatory consultants understand the intricacies of diverse regulatory frameworks, ensuring accurate submissions, compliance, and timely approvals. Our consultants bring a wealth of experience and up-to-date knowledge of global regulatory standards, ensuring your projects meet all necessary requirements. Our team collaborates with yours to fine-tune strategies, optimize resource allocation, and align with your business goals.
• We work in close collaboration with our clients to identify business goals, set and refine strategies, address potential challenges, and celebrate milestones.
• We understand that business needs may change over time and our agility ensures that we pivot when needed. Maintaining an in-house regulatory team can be resource intensive. Outsourcing allows you to allocate your resources more efficiently, reducing overhead costs while maintaining quality. Our team can be scaled up or down based on project needs without the long-term commitment of full-time hires.
• Navigating international markets requires knowledge of local regulations. ProPharma’s global reach ensures compliance across borders, enabling market expansion without compromising quality.