Contract Research & Development

  • Analytical Research
    • Analytical Method Development
    • Analytical Method Validation

  • Formulation Development
    • Oral Solids
    • Oral Liquids
    • Topicals
    • Complex Injectable
      1. Oncology
      2. Opthalmic
    • (Types: Lyophilized, Liquids, PFS, Suspensions)

  • cGMP Manufacturing
    • Scale-Up
    • Clinical Trail Batches
    • Troubleshooting & Tech-Transfer

  • Contract Testing & Stability
    • Stability Testing for all dosage forms
    • Third Party Testing for all dosage forms
  • More than 10+ years of experience in product development for regions like USA, Europe & Mena.
  • Integrated services for new chemical entities, late phase product development and over-the-counter products with focus on quality, speed and cost-efficiency.
  • Clear and executable strategies for product development.
  • Dossier document preparation in CTD/ACTD format.
  • Compilation and review of dossier as per CTD/ACTD/Country Specific.
  • Guideline for East & West African, CIS, Latin & Asian Countries.
  • Legal Application – COPP, Product Permission, FSC etc.
  • Post approval query response till registration obtained.
  • Renewal / Retention Application.
  • Variation Application.
  • Import License.
  • Module 4 & 5 – Clinical & Non-Clinical Dossier.
  • Labelling / Artwork Preparation.
  • Drug Master File preparation.
  • Compilation of dossier as per latest eCTD guidelines for some countries / ANDA preparation.
  • Evaluation and Recommendations of API and Drug Product for IP landscape across the globe.
  • Product, process, method of use patent for USA, Canada, EU and ANZ markets.
  • Formulation patents.
  • Polymorph selection.
  • Patent opinion.
  • Litigation advise and identifying right legal attorney for different markets.
  • Vibratory sifter
  • Rapid Mixer Granulator
  • Rapid Dryer
  • Multi-mill
  • Co-mill
  • Blender- Octagonal Blender and V shaped Blender
  • Tablet compression Machine
  • Bilayer Tablet Compression Machine
  • Mini-Fluid Bed Granulator
  • Bottom spray Fluid Bed Processor
  • Auto-coater for Tablet
  • Blister Packing Machine
  • Leak Test Apparatus
  • Semi-Induction Cap Sealing Machine
  • Sieve shaker
  • Tap Density
  • Disintegration Apparatus
  • Moisture Analyser
  • High speed Homogenizer
  • Auto Clave
  • Dry Heat Sterilizer
  • Lyophilizer
  • Laminar Air flow station
  • Bio-safety cabinmate
  • HPLC
  • GC
  • IR
  • IC
  • UV spectrophotometer
  • Dissolution Apparatus
  • Polarimeter
  • Kalfisher
  • Viscometer
  • Osmolarity Meter
  • pH meter