SoliTech® Solutions

SoliTech® Research and Enabling Technology

One-stop drug development

  • Drug substance and drug development for submission to USFDA or NMPA
  • eCTD format dossier
Drug substance development
  • Structural elucidation
  • Solid form screening and selection
  • Preformulation
  • Crystallization process development
  • Analytical method development
  • CTD format dossier
Analytical Development
  • Analytical method development
  • Analytical method validation
  • Release testing
  • Stability studies
Drug product development
  • Reverse engineering of RLD
  • Excipient and packaging compatibility
  • Formulation design
  • Quality by design
  • Process development
  • Process scale up
  • Stability studies
  • CTD format dossier

Quality consistency evaluation of generic drugs

SoliPharma develops solid orals, injectables and topical dosages for USFDA and China NMPA approval.

Our full-range R&D service assists pharmaceutical companies from early stage strategic planning to product development until commercialization.

Our effective management of BE and clinical studies with domestic and oversea CROs offer reliable in-vivo study results to support drug development and submission.

Our Regulatory Affairs team communicate frequently with the U.S. FDA and NMPA to ensure accurate and up-to-date information.

Our excellent record in GMP, safety, and environmental compliance allows flawless agency inspection.

Regulatory Affair

  • Drug applications in compliance with current agency and ICH guidances
  • Flawless response to agency to ensure clear communication and up-to-date information
Technical package
  • Drug applications dossier in compliance with agency and ICH guidance
  • eCTD dossier preparation submission to USFDA and NMPA
  • Flawless response to FDA and NMPA
  • File encryption and sharing system to protect valuable intellectual properties

USFDA GMP consulting

  • GMP system improve to meet compliance with target markets
  • GMP education course to prepare/manage/escort FDA inspection
Technical package
  • Gap analysis of the current GMP status and target market requirement
  • Multiple audits and reports
  • Improvement measures
  • Mock GMP inspections
  • GMP education course for preparing and managing inspection
  • Escorting FDA GMP inspection

Intellectual property services

Polymorph patents are one of core intellectual properties of pharmaceutical substances. The rational mapping of crystal-related intellectual property is an important strategy for maxium extension of the drug life span. Solipharma provides IP-related advices and technical support to pharmaceutical companies.

Technical package
  • Patent survey and assessment
  • New salt / polymorph / co-crystal screening
  • Patentability assessment
  • Patent application drafting
  • Patent document review