Quality & Regulatory

Our services encompass:

  • Process variation for Registration dossiers
  • European GMP certification (for European locations)
  • CFDA (China) and ANVISA certification (Brazil)
  • Principal ISO norms certified
  • Operational Risk Management
  • CMR compounds authorization
  • European Medicines Agency
  • International Organization for Standardardization
  • CFDA
  • Anvisa
  • Saudi Food and Drug Authority
  • Korean Food and Drug Administration

Manufacturing

We offer:

  • Pilot batch manufacturing (for clinical trials)
  • Scale-up development to process industrialization
  • Toll manufacturing (fluid bed dryer / one pot technology)
  • High-potent compounds capability

Packaging

Our services cover a variety of capabilities including:

  • Blisters PVDC or PVC / Alu
  • Blisters Alu / Alu
  • Blisters in flow-pack seals
  • Sachets
  • Tablet counting for bottles
  • Liquid bottle filling

Galenic forms

Galenic forms available on our network:


  • Tablets
    (simple & double layer)
  • Capsules
  • Sprays
  • Liquids
  • Powders

Analytical

Our services cover a variety of techniques including:

  • Full testing API / RM / FP
  • Stability studies
  • Method development including microbiology
  • Cleaning validation
  • Comparative dissolution studies

Supply Chain

We offer:

  • Warehousing
  • Temperature controlled storage
  • Distribution
  • Export/import

Serialization

Our services cover Toll packaging
integrating our serialization & aggregation capability

(Datamatrix / Tamper evidence)

For our Pharmaceutical services, contact us

Contact us