IND Enabling Studies / Studies for NCEs
Adopting an integrated strategy, we provide comprehensive safety assessments essential for Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and New Drug Application (NDA) submissions, as an integral component of our advanced drug development methodology.
We hold registration under the US FDA with FEI number 3017185612 and the D&B DUNs Number 87094706. Our team of seasoned scientists, originating from esteemed institutions, brings a wealth of expertise to the drug development process. We provide high-quality scientific guidance throughout the drug development cycle, ensuring seamless support from initial stages to project completion. With extensive experience handling IND molecules, we offer personalized assistance in developing tailored methodologies based on various routes of administration, aligning with clinical and regulatory requirements.
Formulation Analysis / Bioanalysis
Multi Species Pharmacokinetics
Safety Toxicology Studies
Genetic Toxicology
Global Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical
regulations.
