Strategic Guidance
Enhancing Insight into the European Market and Optimizing the Positioning of Your Medicinal Product
The European Union, along with the UK and Switzerland, represents a significant market opportunity for product launches. With a combined population exceeding 520 million people, this region surpasses the United States in size. However, navigating the complexities of 29 countries and 26 official languages presents challenges in assessing market conditions and making informed decisions.
Entering the European market requires careful evaluation beyond disease prevalence, market size, and competition. Understanding current guidelines, regulatory pathways, and market access barriers is crucial. Yet, gathering such information can be daunting, hindering decision-making on when and how to enter.
Establishing connections with healthcare professionals (HCPs), patient organizations, manufacturers, laboratories, and distributors across Europe is paramount. Only by integrating comprehensive insights can companies illuminate the path to success in the European market.
VIVA Pharma Consulting specializes in providing factual analysis and deep insights into the European market, empowering pharmaceutical companies to make informed and strategic decisions.
Product Development
Shaping Your Product in Compliance with European Directives
In compliance with European regulations, medicinal products and medical devices must meet stringent standards for safety and efficacy. These regulations differ from those of the US and other non-EU nations. To facilitate a seamless regulatory process within Europe, thorough documentation review and gap analysis are essential.
At VIVA Pharma Consulting, we leverage our extensive expertise to assess in detail existing documentation, pinpoint potential gaps, and facilitate connections with trusted manufacturers and laboratories in the European Union. This comprehensive approach ensures that product development aligns seamlessly with European regulations, streamlining the path to regulatory approval.
Regulatory Affairs
Guiding You Through Every Stage of Regulatory Procedures
For a smooth journey towards regulatory approval in Europe, meticulous attention to detail is crucial. From pharmaceutical development to preclinical and clinical studies, every document must adhere to the correct format and comply with local rules and regulations.
At VIVA Pharma Consulting, we offer comprehensive support from the early stages of development right through to regulatory approval. Our ongoing collaboration ensures the timely gathering of all necessary documentation. Moreover, we prioritize seamless alignment with key stakeholders to facilitate the preparation process.
Given that this regulatory journey spans several years, effective coordination and open communication with our clients are paramount. Our ultimate goal is to secure regulatory approval in Europe, whether through the centralized or national procedure, and we’re dedicated to achieving it through a partnership built on trust and excellence.
Project Management
Supporting Your Teams to Navigate European Projects with Efficiency and Precision
VIVA Pharma Consulting takes pride in offering your team the essential support required to navigate European projects with unwavering efficiency and precision. With a wealth of experience spanning from the earliest stages to the late-stage development phases, our team stands ready to provide comprehensive assistance at every crucial juncture, empowering you to conquer even the most intricate challenges with confidence. From detailed planning to seamless execution, we are committed to ensuring that your projects not only progress seamlessly but also culminate in the successful attainment of your objectives.
Change Management
Guiding Your Teams Through Transition for Sustained Success
Periods of change are always particularly challenging for employees and managers. Uncertainty is high on many sides and it is difficult for everyone involved to show the necessary flexibility. Getting through the familiar “valley of tears” with shock, frustration and depression to finally reaching the desired goal while still achieving business objectives requires strength and often help from outside.
VIVA Pharma Consulting is on hand with help and advice during these phases.
From meticulous planning to hands-on implementation, we work tirelessly to ensure a seamless transition period that fosters uninterrupted success. By facilitating seamless adaptation to new initiatives and strategies, we empower your teams to embrace change with confidence, driving continued growth and prosperity for your organization.