We collaborate with a wide variety of pharmaceutical and biotech companies in HPC and provide solutions to different challenges encountered in early development up to commercialization. We support:

• New biotech and start-ups who are making new small molecules, peptides, and complex drug conjugates that require the highest quality advice to take them through concept to clinic.
• Pharmaceutical companies with proven track records and looking to have a reliable and flexible partner to develop formulations, provide analytical services, optimize processes and commercialization.
• Manufacturers of generic drugs that need effective development, technology transfer, validation and submission of registration.
• Companies facing issues in API synthesis need route mapping, process optimization, scale up support, and robust manufacturing solutions.
• Organizations dealing with impurity profiling or impurity-related problems, such as identification, characterization, method development, and control strategy development.
• Companies with low-solubility or complex dosage forms requiring specialized formulation expertise.
• Organizations navigating regulatory pathways that require organized support of INDs, IMPDs, DMFs, NDAs, ANDAs, and interrelation of global regulations.
• Asset holders and investors in need of technical due diligence, asset analysis, licensing, and acquisition analysis.
• Companies preparing for audits and compliance reviews requiring GMP/GLP audit preparedness, mock inspections, and quality system reinforcements.

HPC is a strategic partner throughout all phases of the product life cycle with experience in sourcing to supply chains, synthesizing APIs, process chemistry, formulation development, analytical and stability testing, compliance and regulatory affairs, and investor engagement.