Pharmaceutical & BioTech

A multinational pharmaceutical company with a vast portfolio of medicinal products across more than 50 countries including EU, US, Canada, LATAM, MENA, Africa, Asia Pacific, EAEU/CIS, Balkans, and Central and South America.

• RPN implemented a fully integrated and experienced Regulatory Affairs (RA) function to maintain efficiency across global markets.
• Devised a proactive strategy for timely and accurate regulatory submissions in conjunction with various company departments.
• Achieved significant time and cost savings through effective global RA management.

The client needed efficient Regulatory Affairs maintenance across a vast global landscape for its medicinal products. This entailed managing regulatory submissions in diverse regions, coordinating with multiple company departments to ensure timely submissions, and preemptively identifying and addressing any gaps or critical issues.

RPN established a comprehensive RA function, including a Senior Director and a dedicated team, to manage the project’s scope and deliverables. We developed a strategy for product launch, distribution, and promotion in each market, ensuring a systematic approach to predict project risks and implement necessary variations. Our team worked closely with the client’s headquarters and affiliates to coordinate all regulatory submissions and manage artwork updates globally.

The client benefited from a seamlessly integrated RA function, which led to effective management across all target countries. This resulted in considerable time and cost savings, and ensured all regulatory submissions were accurate and timely. The client’s global footprint was strengthened, and they could maintain continuity and high volume for strategic projects with ease.