Pharmaceutical & BioTech

Planning and executing a successful product launch is a multifaceted endeavor that demands synchronized efforts across various departments. RPN is specialized in cross-functional collaboration to ensure a cohesive, effective launch strategy.

RPN assists in developing a comprehensive roadmap that details the strategic and tactical steps necessary for a successful product launch, to overcome the challenges that arise during the process.

First, timing is key. Determining the optimal start time for the launch plan is a decisive consideration, applicable to small companies, biotech firms, and even more established pharmaceutical companies. Each launch is unique, just like the product, so it is imperative to tailor the approach accordingly. Additionally, if opting for an early access program, commonly observed in the case of orphan drugs, careful thought must be given to the transition period between the program and the future commercial launch.

Organizing the launch sequence requires meticulous planning, taking into account the necessary resources and key stakeholders at both global and local levels. Understanding the specific requirements of each market is crucial to differentiating between mandatory elements for the launch and those that can be deferred or implemented later. Every product aspect must be considered: for instance, launching a biologic exclusively distributed in hospitals differs significantly from introducing a small molecule available solely in pharmacies.

The initial launch also represents a transformative phase for the organization: the establishment of shared services, back-office functions, commercial standard operating procedures (SOPs), finance and data systems, decision-making bodies, and field-based personnel must be well thought out.

A well-defined roadmap serves as a valuable tool to ensure timely execution of all necessary elements while respecting interdependencies. Effective coordination is crucial to avoid any disconnects between individual workstreams that could hinder the commercialization process.

The RPN regulatory team provides an overview of the regulatory environment on a country-by-country basis. This assessment will identify the personnel, licenses, and mandated systems needed in each country.

Key elements to be considered in order to comply with applicable regulatory requirements during product launch include:

• Information to be reported on the packaging (e.g., Blue Box with locally required data), which should be anticipated to enable the rapid manufacture of the drug.
• Traceability-related requirements.
• Mandatory roles (Local Representative for Pharmacovigilance, scientific services, etc.).
• Product registration in local databases.
• Congresses and promotional initiatives and related materials.
• Launch notification.

RPN will assess the Quality Management System and will outline and implement the essential Standard Operating Procedures (SOPs) and quality agreements required at both the European Medicines Agency (EMA) level and locally. All aimed at ensuring compliance with quality standards and regulatory requirements.

RPN provides guidance on navigating market access challenges and optimizing Pricing & Reimbursement strategies, and full support for the implementation of such strategy.

RPN offers insights and coordinates the design of a European organization, to define and integrate the commercial, operational, and supply chain structure with considerations for regulatory, market access, and quality compliance.

This advice in designing and establishing the optimal commercial organization structure is aimed at ensuring that the right resources are in place to support the launch.
Planning the resources and budgets required for a successful product launch should ideally commence well in advance, especially for companies new to commercialization.