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Development

Analytical  
Method development and validation - Assay
  - Dissolution
      Solid dosage forms
      Semi-solid dosage forms
  - Related substances
   
Formulation  
Product development - Solid dosage forms. Tablets and capsules
      Immediate release
      Modified release
      Sublingual tablets
      Chew tablets
      Lozenges
      Vaginal
  - Liquids and Semi-solids
      Syrups
      Eye/ear drops
      Gels
      Suspensions
      Emulsions
      Ointments and creams
  - Parenterals
   
Product development processes - Laboratory scale development batches
  - Scale-up
  - Validation of production processes
  - Lifecycle management
      Variations
      Post registration amendments (SUPAC)
      Bio-waivers
   
Stability testing  
Stability indicating Analytical method development and validation  
   
Stability testing storage conditions, ICH/MCC Guidelines - Real time conditions 25’C/60 %RH (30’C/65 %RH as from 1 July 2010)
  - Accelerated conditions 40’C/75 %RH
  - Cold storage conditions 40’C +- 3’C
  - Cyclic conditions on request
   
   
   
   

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