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
  • 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.