Our Services

Documentation Services

Through our In-house service

Master Document Preparation

  • Method Validation Protocols & Reports
  • Method Transfer Protocols & Reports
  • Method Verification Protocols & Reports
  • Method Feasibility Protocols & Reports
  • Standard Test Procedures (STP)
  • Standard Operating Procedures (SOP)
  • Specifications
  • Record of Analysis (ROA)
  • Change Controls & Deviations
  • Equipment Qualification Protocols & Reports
  • Other Regulatory & Laboratory Documents
  • Stability Protocols & Compilations
  • PowerPoint presentations
  • Excel sheet validations
  • Any other requirements, as per client

Review of Executed Documents

  • Method Validation, Verification, Transfer & Feasibility raw data & Reports
  • All Laboratory testing raw Data

Regulatory Filing Support

  • CTD / eCTD / NeeS Dossier Preparation
  • Country-Specific Dossier Services (US, FDA, EMA, MHRA, TGA, ANVISA, WHO PQ, GCC/Middle East, ASEAN, SAHPRA (Africa), CDSCO (India))
  • DMF (Drug Master File) Preparation (US DMF (Type II, III, IV, V), EDMF (European DMF) & CEP applications, Japan DMF (JDMF) submissions)
  • Regulatory Strategy & Submission Support (Gap analysis of existing dossier vs. country-specific requirements, Conversion of ACTD to CTD or NeeS format, Dossier lifecycle management)
  • Regulatory query response support

Analytical Services

(Through our In-house & External FDA approved contract service providers)

  • Analytical method development & validation & Verification & feasibility
  • Stability studies & impurity profiling
  • Quality control testing & release analysis
  • Pharmacopoeia testing (USP, EP, JP, IP)
  • Microbiological & bioanalytical services
  • Extractable & leachable studies
  • Any other requirements….

    • Type of Analytical Methods

    Chromatographic Methods (Separation & Quantification Techniques)

  • High-Performance Liquid Chromatography (HPLC) – Assay, impurity profiling, stability testing
  • Ultra-High-Performance Liquid Chromatography (UHPLC) – Faster, higher-resolution separations
  • Gas Chromatography (GC, GC-MS, HS-GC) – Volatile compounds, residual solvents
  • Ion Chromatography (IC) – Analyzing ionic compounds and excipients
  • Size Exclusion Chromatography (SEC) – Protein and polymer analysis
  • Supercritical Fluid Chromatography (SFC) – Chiral separations
  • Thin Layer Chromatography (TLC, HPTLC) – Rapid qualitative analysis

    • Spectroscopic Methods (Identification & Structural Analysis)

  • Ultraviolet-Visible Spectroscopy (UV-Vis) – Concentration and purity analysis
  • Fourier Transform Infrared Spectroscopy (FTIR) – Functional group identification
  • Nuclear Magnetic Resonance (NMR) Spectroscopy – Structural characterization
  • Mass Spectrometry (MS, LC-MS, GC-MS) – Molecular weight determination, impurity analysis
  • Atomic Absorption Spectroscopy (AAS) – Heavy metal analysis
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS/ICP-OES) – Trace elemental analysis
  • Fluorescence Spectroscopy – Sensitive detection of fluorescent compounds

    • Titrimetric Methods (Quantitative Analysis by Reaction with a Reagent)

  • Acid-Base Titration – Determination of acidic or basic drug content
  • Redox Titration – Oxidation-reduction reactions for compound estimation
  • Complexometric Titration (EDTA Titration) – Metal ion determination
  • Non-Aqueous Titration – Used for weak acid/base drugs in non-aqueous media

    • Physicochemical Methods (Physical Property Analysis)

  • Dissolution Testing – Drug release rate from formulations
  • Disintegration Testing – Tablet/capsule breakdown assessment
  • Melting Point & Boiling Point Determination – Purity and identity confirmation
  • pH Measurement – Acidity/alkalinity analysis of solutions
  • Viscosity Testing – Rheological studies of semi-solids and liquids

    • Thermal Analysis Methods (Stability & Degradation Studies)

  • Differential Scanning Calorimetry (DSC) – Polymorphism and thermal behavior
  • Thermogravimetric Analysis (TGA) – Weight loss due to decomposition
  • Differential Thermal Analysis (DTA) – Phase transitions and decomposition studies

    • Electrochemical Methods (Ion & Electron Transfer-Based Analysis)

  • Potentiometry (pH Meter, Ion-Selective Electrodes) – Ion concentration measurement
  • Conductometry – Conductance measurement of electrolyte solutions
  • Polarography & Voltammetry – Heavy metal and trace element analysis

    • Microbiological & Bioanalytical Methods (Biological & Drug-Interaction Studies)

  • Microbial Limit Testing (MLT) – Determining microbial contamination
  • Endotoxin Testing (LAL Test) – Detecting bacterial endotoxins
  • Bioassays (Potency Assays) – Measuring biological activity of drugs
  • ELISA (Enzyme-Linked Immunosorbent Assay) – Drug and protein quantification
  • Cell-Based Assays – Drug interaction and cytotoxicity studies

    • Forced Degradation & Stability Studies (ICH Guidelines Compliance)

  • Photostability Studies – Light-induced degradation testing
  • Hydrolytic Degradation – Stability under acidic/basic conditions
  • Oxidative Stress Testing – Stability under oxidative stress conditions
  • Thermal Degradation Studies – Heat stability testing

    • DO YOU HAVE ANY OTHER REQUIREMENTS?

    All the Tailored Solutions to Meet Every Client’s Needs!

    We can fulfill client’s any requirements by sourcing from quality and reliable suppliers while serving as the front-end partner to deliver seamless and efficient services

    Supply Chain

  • APIs, Raw materials, Intermediates, Excipients
  • Reference Standards, Impurity standards
  • Columns, Chemicals, consumables
  • Instruments, Equipments
  • Glassware
  • Finished products
  • Any others..

    • Contract development & Manufacturing

  • Pharmaceuticals (API, Formulations)
  • Nutraceuticals

    • Other Services

  • Pharmacovigilance
  • Others…