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.
SoliTech platform – form concept to submission
Product Lifecycle Mgmt
- Polymorph Screening
- Salt Screening
- Solid Form Screening And Selection
- Crystallization Process Development And Scale Up
- Pre-formulation Evaluation
- Drugs Analytical Methods
- Drug Product Development And Manufacturing
- One-stop Service For Generic Drug Development
- Solutions For Consistency Evaluation Of Generic Drugs
- ANDA Filing And Official Response To FDA And CFDA
- FDA GMP Consulting
- Intellectual Property Services
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
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.