- ul. Krakowskie Przedmiescie 13 , Warszawa 00-071, PL
- +48501076956
Edge Pharma is a premier consulting and sourcing company dedicated to closing the gap between the European and Asian pharmaceutical markets. We specialize in the high-stakes world of API sourcing, regulatory compliance, and technology transfer, providing our partners with the security and transparency they need to thrive. Our foundation is built on deep industry expertise and a commitment to improving global health by ensuring that essential pharmaceutical ingredients move safely and efficiently across borders.
Our team is composed of seasoned pharmacists, regulatory specialists, and international trade experts who understand the nuances of both Western and Eastern business cultures. We don’t just consult; we act as an extension of your own team, ensuring that every project—from a simple API delivery to a complex tech transfer—is handled with precision.
Peter is an accomplished Chief Technical Officer and China Office Director with a proven track record in R&D, technology, and production within the pharmaceutical and drugs industry. With extensive experience, he possesses in-depth knowledge of law and regulation compliance, ensuring seamless operations in complex regulatory environments. Peter has also established a robust network of collaborators in the local market, enhancing the company's reach and effectiveness in China.
Karol is a seasoned professional with extensive expertise as a CFO and Consulting Director. With a diverse background in project and business management across various industries, Karol brings a wealth of experience to the table. Having worked in both European and emerging markets, particularly in Greater China, Karol offers a unique blend of Western education and values, coupled with a deep understanding of cross-cultural collaboration.
Diego is an experienced sourcing, technology, and compliance professional in the pharma and drugs industry. With expertise in procuring quality pharmaceutical products, Diego ensures the availability of essential medications. By staying updated on the latest industry advancements, Diego leverages technology to streamline processes and optimize efficiency. Diego's meticulous approach to compliance ensures adherence to regulatory standards, guaranteeing the safety and efficacy of the drugs supplied.
Cherry is an accomplished logistics director with a proven track record of ensuring on-time deliveries in diverse transportation networks. With expertise in establishing efficient delivery chains across air, rail, and sea transport, Cherry brings extensive experience and knowledge to optimize logistical operations. Their meticulous approach and strategic planning skills make them an invaluable asset in achieving seamless and reliable supply chain management.
Maciej is an Assistant Professor at Polish Academy of Sciences. With a strong background in research and development (R&D), Maciej serves as a science advisory expert, providing valuable insights and guidance in scientific projects. With extensive expertise in their field, Maciej contributes to advancing scientific knowledge and fostering innovation.
We operate under the firm conviction that the pharmaceutical industry leaves absolutely no room for guesswork, which is why our operational model is built upon a seamless integration of strategic intelligence, compliance-focused execution, and sustainable partnership. This rigorous process begins with an exhaustive evaluation of market landscapes, manufacturer reliability, and regulatory hurdles long before any formal agreements are signed, ensuring a foundation of absolute technical and commercial viability for our clients. We then transition into a phase of meticulous execution where our team manages the entire documentation trail—including the complexities of CEP, ASMF, and DMF dossiers—while conducting stringent on-site audits to guarantee that quality and safety standards are never compromised. By prioritizing long-term supply chain resilience and proactive risk management, we provide our partners with the ongoing expert support necessary to protect their operations from global volatility and ensure that their vital production lines never stop.
We specialize in sourcing high-purity Active Pharmaceutical Ingredients (APIs) and hard-to-find raw materials, specifically bridging the supply chain between China and the European Union.
We conduct on-site audits and documentation reviews to verify that our manufacturing partners meet applicable GMP requirements, EU regulatory expectations, and international quality standards.
We also assess quality systems, batch documentation, traceability, CAPA procedures, and product-specific regulatory files, with ongoing monitoring where required.
Yes, we provide full regulatory support in preparing and managing Certificate of Suitability (CEP) and Active Substance Master Files (ASMF) to accelerate market access.
Absolutely. We provide strategic consulting, market analysis, and regulatory navigation for EU firms looking to establish a presence or distribute products in China.
We facilitate the technical exchange between R&D and production, ensuring that manufacturing processes are successfully scaled and compliant across different regions.
We implement transparent tracking, logistics optimization, and multi-source strategies to protect our clients from global shortages and delivery delays.
The pharmaceutical landscape is highly regulated and culturally distinct; we provide the local presence and technical knowledge needed to avoid costly legal and operational mistakes.
