SoliPharma relies on its keen foresight to target products that both require high demands/leaps in current technology are unique in its field to conduct product development for high-end generic and innovative drugs.
SoliPharma provides one-stop service to our partners worldwide for target markets including China, US and rest of world. SoliPharma excels at pharmaceutical solid-state research and enabling technology, especially in the development of generic and products with challenging issues, such as narrow therapeutic index drugs, poorly soluble drugs, low stability drugs, highly variable drugs, etc.
SoliTech® Solutions identify optimal strategies, develop products and methods, supply products, organize clinical studies and complete product registrations. In our nine years of excellent research, we have embraced 300+ pharmaceutical companies to advance 500+ challenging molecules in their product development pipeline.
SoliTech® technology covers early API development (solid form screening/crystallization process), drug product development (formulation/analytical chemistry) anddossier compiling to obtain the final approval of market authorization (FDA GMP/regulatory affair).
SoliTech® Overview – from Concept to Submission
Product Lifecycle Mgmt
- Polymorph Screening
- Salt Screening
- Solid Form Screening & Selection
- Crystallization Process Development
- Pre-formulation Evaluation
- Analytical Method Development & Validation
- Formulation Development
- One-stop Product Development
- Quality Consistency Evaluation
- Regulatory Affair
- USFDA GMP Consulting
- Intellectual Property
Solid dispersion screening
Polymorph interrelations analysis
Processibility of polymorphs
Prior art evaluation
Patent conception and writing
Crystallization process development
Analytical method development and validation
Testing and characterization
Testing and characterization
Method development and validation
One-stop service for drug development
Drug substance development
Drug product development
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.
USFDA GMP consulting
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.