HeliPharm Consulting LLC is offering the following services to pharmaceutical companies:

• 19 years of CMC leadership and technical experience in the pharmaceutical industry from early-phase programs to commercial
• Offering expertise in CMC operations, and technical consulting including pre-formulation, formulation development, process scale-up and optimization, tech transfer, registration, and validation of solid oral products (BCS I through IV compounds)
• Global CMO management: Request for proposal, CMO selection, project and program management, technical audits, CMO assessments, overseeing CMO for solid oral formulation from development through registration, process validation and commercialization
• Regulatory Technical Writing: extensive knowledge authoring Module 3 for US and global regulatory submissions (4 NDAs, over 10 INDs, including 4 breakthrough therapy designation drug development programs received from the FDA)