Operational Modules
Strategic Analytical Research
- Identification and Characterization of Impurities, Isolation of Impurities through Enrichment Analytical Method Developments (APIs and FDFs); QbD Approach for Development – Training and Implementation
- Determination of Physical and Chemical Properties of APIs and of APIs extracted from FDF (Drug Products)
- Forced Degradation Studies, Carryover Studies, Impurity Profiling up to Evaluation of Stability Studies
- Quantitative Estimation of Excipients or Targeted Compounds in a FDF; API Sameness Study
- Reference Product and Generic Product Comparative Study (Qualitative and Quantitative)
- We carry out, full dosage form evaluation. We can identify and quantify each ingredient in the dosage form.
- CMC, HPC, HPMC, HPMCAS, Stearates, Lactose, Polysorbates, Kollidon, Simethicone, Ions, and many more are in our list.
- We are also taking up quantification tasks on Lecithin.
- Please let us know of your GOAL so that we can provide our plan of action.
- Establishing Interaction of Drug – Drug or Drug – Excipients, if any, Interpretation and Report Preparation
- Approach, Design, Protocol, Execution for various Components Extractables and FDF’s Leachables Estimation
- Functional Group Alerts, QSAR, Literature Based Approach
- Determination of GTI Limits, Method Development and Validations; AMES and further Genotoxic Evaluation
- Approach, Assessment, Protocol Design, Execution and Final Submission
- Compliance Certification with USP < 232>, < 233> and ICH Q3D Guideline
- Design, Pharmacopeial Specification Evaluation and Comparison; Harmonization of Specifications
- Design of Protocol, Execution and Report Preparation as per USP < 1225>, <1226>and ICH Q2(R1)
- GLP Implementation and Mock Audits; SOP Design, Training, Implementation
- Qualification of Instruments / Equipments for Lab and Mfg.; URS, DQ – IQ, OQ, PQ Designs, Documentation – Implementation
- Laboratory Audits and Compliance; Vendor Qualification and Audits
- Carrying out Projects under the Scope of Six Sigma Black Belt(ASQ Model)
- Data Integrity(Handling and Awareness)
- CSV(Computer System Validations) – URS, Approach, Protocol Design and Execution; SOP Design and Implementation
- DMF, ANDA Preparation.Approach, Evaluation, Execution, Preparation of Draft Response for Analytical Technical Queries
Characterization
- Structural Characterization(Complete Structural Elucidation with Report)
- Polymorphic Characterization and Quantification(as Impurity and Ratio – of – Polymorphs)
- Particle Size Characterization(Method, Evaluation, Specification, and Comparison of Data from various Techniques)
- Evaluation of Morphological Properties
- Reference / Working / Impurity Standard Qualification(Approach and Execution)
QbD (DoE and Execution)
- Product Development
- Method Development
- Strategic Support for your Developmental Needs
- Development of Methods for Post-processed Samples
- Quantitative studies for Clinical and Pre-clinical applications
- Failure Investigati
- ADME
- Metabolite – Identification and Characterization
- Intact and Subunit analyses
- Proteins Antibodies
- Primary, Secondary and Tertiary order Characterizations
- Impurity Profiling
- Analysis of Antitoxins, Vaccines, Hormone Extracts, Recombinant Proteins
- Development of Screening Methods
- Development of In-process Check Metho
You need us at your Lab or Office for a learning session, come along. You won’t be disappointed. Our commitments stretch upto the final settlement of the task at hand.
- Herbal Scientific Community
- Cosmetics
- Packaging Industry
- FMCG
- Food and Agro
Send in your queries, we are opening up this vertical soon.