PRODUCT DEVELOPMENT
Going through each stage of the development of healthcare innovations together
Supporting product development from concept to commercialization through integrated product development
At the forefront of an ever-changing regulatory and technological environment, PLG provides global support for developing, registering, launching and ensuring patient access to healthcare innovations globally. Successful drug development requires the integration of many complex and varied cross-functional activities. Our product development offerings guide you through all phases – from early-stage development to initial approval and market introduction. With deep expertise in key functional areas, we provide strategic advice and operational support for regulatory, non-clinical, clinical CMC, quality and market access. Our global presence ensures that we understand and anticipate regional and local requirements. Our teams of experts in pharmaceuticals, biologics, biosimilars, medical devices, and self-care, and borderline products are dedicated to understanding your needs to support you through the entire process. Our integrated solution approach reduces cost and complexity and helps to ensure commercial success. As a partner to biopharma, biotech, medtech, and consumer care companies, we aim to secure expedited development and patient access to innovative healthcare solutions.
Biopharmaceutical drug development services
We assist in advancing innovative drugs and therapies, including their medical device component(s), to ensure their quality, safety, and efficacy and to expand global patient access. Our expertise offers biopharma support, expediting biopharma development from preclinical to late-stage clinical development and registration.
Medical device services
We empower medtech and IVD innovation by supporting quality, clinical, and regulatory affairs. With consistent and dynamic advancements in the medtech and IVD sectors, our consulting support keeps you updated, laser-focused, and on track in designing, testing, registering, and launching your innovative product in the global markets.
Healthcare product services
Succeeding in the self-care market (health & beauty) requires navigating different regulatory frameworks and statuses. Addressing relevant indications and claims involves understanding the complexities of regulations for nutraceuticals, cosmetics, medical devices, and biocides. We provide a comprehensive regulatory strategy, along with regulatory and scientific support, to ensure the development of your products, their marketing authorization, and their global compliance.
PLG’s knowledge and experience in the product development space helps clients meet their strategic, scientific and commercial goals.
Despite the ever increasing scientific and regulatory complexity and rising costs early phase drug development is seeing explosive growth and innovation. Our extensive knowledge and experience in product development guide clients through the intricate process of bringing groundbreaking therapies to market. Our critical-thinking skillset and innovative mindset ensure you receive the best solutions to deliver a safe and effective product. Collaborating with established pharmaceutical and biopharma companies and biotech and medtech startup companies, we challenge the status quo and enable validation of innovation and regulatory strategy. Our expertise extends globally, ensuring healthcare innovations enter the market efficiently and addressing the unique challenges faced at every step of product development
Product development consulting Solution
Many companies treat product development as a sequential, phase-driven process during which a product is taken methodically in a more or less linear fashion from discovery through approval. New product development is not in fact linear and requires integrated collaboration among different functions and stakeholders throughout the program. Our integrated product development approach ensures cross-functional strategies and plans come together seamlessly to achieve commercial success. In addition to offering integrated solutions we also offer a la carte services for each of the various funcitons involved in product development .
From first-in-human (FIH) studies to full market approval Solution
Guiding product development on a global scale, our goal is to ensure regulatory standards and efficient progress from initial FIH stages to final approval. We facilitate the entire product lifecycle of global pharmaceutical product development.
E2E Medtech quality compliance and regulatory affairs Solution
Our comprehensive services cover all aspects of medtech, from design and development to quality compliance, ensuring that your medical devices meet all necessary standards and regulations.