Description
The J. Molner Company, headquartered in Estonia, is a comprehensive generic Contract Research and Development Organisation (CDRO) with extensive experience in the formulation and development of topical, liquid, and sterile dosage forms. The company offers specialised programmes to support In Vitro Release Testing (IVRT) for semi-solid bioequivalence, as well as Post Approval Change Management for both existing and shelved applications. J. Molner is EU-GMP release capable and holds a Mutual Recognition Agreement (MRA) with the FDA.
Services include:
- 505(b)(2)
- Accelerated Stability Studies
- Analytical Services
- Assay Development
- Auditing
- Biosimilars
- Chemical Analysis
- Raw Materials
- Chiral Separations
- R&D
- Chromatography
- Consulting
- Regulatory
- Contract Research (CRO)
- Custom Manufacturing
- Dissolution Testing
- Dosage Form Development
- Drug Design
- Drug Development
- Excipients
- Forced Degradation Studies
- Process Development
- Formulation Development
- In Vitro Testing
- Testing
- Lot Release Testing
- Materials Analysis
- Photostability
- Physical Testing
- Preformulation
- Process R&D
- Quality QA/QC
- R&D Services
- Raw Materials Analysis
- Regulatory Affairs Consultants
- Site Selection
- Stability Studies
- Stability
- ICH
- Supply Chain Auditing
- Technology Transfer
- UV-VIS Spectrophotometer Analysis
- Validation
- Wet Chemical Analysis
J. Molner is dedicated to providing innovative solutions tailored to the unique needs of the pharmaceutical industry. For more information, please visit jmolner.com.
Capabilities
- Accelerated Stability Studies
- Analytical Services
- Assay Development
- Auditing
- Biosimilars
- Chemical Analysis
- Chiral Separations
- Chromatography
- Consulting
- Contract Research (CRO)
- Custom Manufacturing
- Dissolution Testing
- Dosage Form Development
- Drug Development
- Excipients
- Forced Degradation Studies
- Formulation Development
- ICH
- In Vitro Testing
- Lot Release Testing
- Materials Analysis
- Photostability
- Physical Testing
- Preformulation
- Process Development
- Quality QA/QC
- Raw Materials
- Raw Materials Analysis
- Regulatory Services
- Research & Development
- Site Selection
- Stability Studies
- Supply Chain Auditing
- Technology Transfer
- Testing
- UV-VIS Spectrophotometer Analysis
- Validation
- Wet Chemical Analysis