Small molecules, Biologicals,Peptides and Vaccines

HELICON MEDICAL

Project study, Evaluation and Planning

 

  • literature review
  • Prior Art & freedom to operate
  • life-cycle management approach
  • project planning
  • quality by design

formulation & DEVELOPMET of pHARMACEUTICALS 

Formulation

 

  • development of analytical methods
  • formulation matrix
  • generation of prototypes
  • in house and external evaluation
  • stability studies

Manufacture 

 

  • provision of technical instrucion for manufacture
  • process adaptation for gmp manufacture
  • identify and Liase with contractors (CMO)
  • support manufacturing, protocols and registers
  • support for project management

Toxicology & Regulatory

 

  • subcontract glp toxicology
  • support for for formal stability studies
  • liase with ema for scientific advice
  • continuous risk assessment
  • suport for Clinical trial aplication

CLinical Trials

 

  • elaborate Clinical Trial Protocol and investigator brochure

  • Liasion with ethical comitees and medical centres

  • Liason with regulatory authorities

  • clinical study monitoring

  • Final Study Report

Drug Formulation & Stabilisation Services