Description
Pharmachem Access / NIcht bearbeiten, doppelt Our company has been engaged, since 2001, in providing expert services for cGMP Product Development, Regulatory Compliance and Business Process Management to small and mid-Size Pharmaceutical, Biotechnology, Biologics, Diagnostic, Medical Devices and Allied Health Industries. Our Principals and associates are proficient in development, implementation and management of diversified projects from concept to commercialization involving the integration of scientific principles, regulatory aspects and business requirements. In today’s market, ‘timing’ is the key. Whether it is clinical or commercial Active Pharmaceutical Ingredients (APIs), Rx and OTC drug products (such as Oral Solids, Semi Solids, Liquids, Sterile Injectables and Vaccines), Diagnostic products (such as for Oncology) or Medical Devices (such as those used for Anesthesia and Drug delivery), we assist the stakeholders to develop innovative and commercially viable cGMP compliant quality products. We identify and fill in the required project resources for timely launching of new Supply Chain and cost effective maneuvering of Post Approval Changes throughout the product life cycle to maintain its cost competitiveness. We provide vital regulatory compliance and customer relationship management services focused on ‘first sales’ of cGMP regulated products while providing stewardship to client’s global marketing efforts. With our global experience and years of proven multidisciplinary expertise, we deliver situation specific solutions to transform our client’s vision and strategy to reality. With our ability to combine the best of global talents, we ensure our clients achieve superior business performance.