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Development

PEPTAS PHARMA's development scientists celebrate each workday by combining their manufacturing science knowledge with their passion for innovation.


Formulation, Process and Analytical Development


The complete, integrated development services are designed to connect with the specific needs of various product development –

•    From material characterization, feasibility studies, formulation development, process development, tech transfer, scale-up studies, analytical development, to stability studies. 
•    In addition, we conduct QbD - based product development DoE's and trials. 
•    We have the capabilities and expertise to support scientific discovery advance into commercial production.

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Formulation Development

 

  • Literature Search and Technical Patent Review

  • Pre-Formulation Development

  • Drug-Excipient Compatibility Studies

  • Formulation Process Development and Optimization

  • Scale-Up and Technology Transfer

  • Process Validation Studies

  • Packaging Development Studies

Analytical Development

  • Analytical Method Development for Assay, Content Uniformity, Related Substances, Dissolution etc.

  • Analytical Method Validation

  • Forced Degradation Studies

  • Method and Site Transfers

  • Specification Development

  • ICH Stability Studies and Stability Sample Analysis

Quality and Regulatory

  • CTD Filings

  • Dossiers Meeting Various Global Requirements

  • IND / NDA and ANDA Support Documentation

  • Post Approval Changes and Related Regulatory Filings

  • Licensing

Capabilities

Dosage Forms

  • Oral dispersible films (Nutraceuticals/Pharmaceuticals)

  • Transdermal Patches / Ointment

  • Tablets / Capsules

  • Powders for Suspension

  • Liquid Oral Formulations

  • Injectable Products

Technologies

  • Immediate/ extended Release Dosage Forms

  • Orally Disintegrating Tablets

  • Multiple Unit Pellet System (MUPS)

Other

  • Quality Auditing

  • Quality Services

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