Analytical development is one of the key to the Pharma Industry. We at NUVO help you achieve the best analytical development partner for yourformulation and API. With so many years of experience in the Industry, we can assist with right contract research organization (CRO) partner selection for the analytical method development based on the market entry, type of product and formulation, regulatory approvals and knowledgebase of the partner. Our CRO partners have state of the ART analytical Laboratory infrastructure for formulations and API. We develop the method and perform it validation as per ICH standard requirements and also support the method transfer to the facility. Our services are not only limited to method development and stability but we can cater to the complete end to end analytical solutions.
We cater to global Analytical development services for formulation and API – US FDA, EU health authorities, MHRA, Indian market, LATUM, GCC, SA, Rest of the world markets
Following are the brief list of services for product development, we as a team can take up for API and Formulations:
- Analytical Method Development
- Analytical Method Validations
- Impurity Profiling and Characterization
- Raw Material Qualification & Characterization
- Structure Elucidation & Impurity Identification
- Analysis as per USP,EP,BP,IP, CP,JP,etc.
- Stability studies as per ICH guidelines
- Stability chambers catering to all zones
- Photo stability
- Bulk stability
- In-use stability study
- Forced degradation Studies
- Dissolution Profiling
- Trace metal analysis
- Routine Analysis
- Elemental impurity analysis
- API Characterization
- Solubility studies
- Documentation as per ICH
- Method Transfer at CMO Site
- Development of Paragraph I, Paragraph II, Paragraph III and Paragraph IV
- Analytical development to supports NDA/ANDA, 505b(1) and 505b(2), EU-MAA, ROW
- Analytical Method Development –API and diverse dosage forms for regulated markets like USA, EU, Australia, Turkey etc.
Genotoxicity studies:
- In silico assessment for Genotoxicity (GTI)
- We use Statistical (TOPKAT)and knowledge based approach (Derek Nexus, Lhasa) for FTI assessment
- Alert assessments
- Genotoxic assessments will be performed for given set of compounds/impurities using (Q)SAR methodologies that predictthe outcome of a bacterial mutagenicity assay using Knowledge (Derek Nexus) and Statistical (TOPKAT) based approaches.
- Automated report will be generated by the Derek Nexus interface and TOPKAT along with complete prediction profile.
- Expert review followed by Derek Nexus assessment.
- Detailed report along with expert review will be generated, reviewed, and signed report will be provided
Microbiology Capabilities:
- Microbial Limit test
- Antimicrobial Efficacy test
- Environmental Monitoring by settle plate, Air sampling, Finger Dab , Contact plate & swab analysis.
- Water chemical and microbial analysis
- Bacterial endotoxin test
- Antibiotics and vitamins assays
- Raw materials/excipients analysis as per Pharmacopeia’s
- Disinfectant effectiveness Testing
All the necessary equipment’s and Lab set up are available for performing the different types of analysis. To list few HPLC, GC, LC/MS, IR and UVSpectrophotometers,AAS, DSC, Potentiometer Stability chambers, , Karl Fischer,Dissolution Apparatus and many.
