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Services

Regulatory Affairs

Dossier compilation for Regulated markets like

USA, Europe, UK, Canada, Australia, New Zealand, Brazil, Mexico...

Dossier compilation for
Semi-regulated / Non-regulated market

Query reply

Variation filling

Site variation

Dossier review based on country guidelines

Regulatory training

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Formulation & Development

Formulation development based on QbD system for

Tablets

Capsules

Liquid Injectables

Dry Powder injectables

Liquid

Creams

Ointments

Formulation development for specialized products
Formulation development for Oncology products

Analytical Development

API Testing

Finished product testing

Method development

Analytical Method Validation

Analytical Method Verification

Technology Transfer

  • Technology Transfer from FnD lab to Scaleup batch
  • One manufacturing unit to another manufacturing unit

Plant Audits & support

  • As per the WHO guidelines
  • As per PIC/s guidelines
  • As per PIC/s guidelines

Regulatory Trainings

  • SOP related trainings
  • Dossier related trainings
  • Audit related trainings
  • Regulatory related trainings
  • Formulation development related trainings
  • Analytical lab related trainings
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To get to know what kind of services
we can provide please download brochure

Dwonload Brochure