TECHNICAL

World-class technical &
regulatory expertise

TECHNICAL

World-class technical &
regulatory expertise

WHAT ABEX CAN OFFER YOU

  • IP Protection & Management
  • Regulatory Consultancy Services
  • Extedo eCTD software solutions, eCTD consultancy services, training & dossier preparation
  • GMP audit, Technical, & pharmacovigilance services
  • Co-development opportunities

“Our offerings are non-conflicting in all aspects”

Anita Smal, ABEX director

Read More
  • Management and protection of Intellectual Property for key strategic partners
  • Provide complete regulatory services and MCC liaison
  • Product registration applications; Marketing Authorisation management and maintenance
  • Offering electronic Regulatory Affairs solutions, services and training (eg in the eCTD field) to the pharmaceutical industry, as a professional partner of Extedo
  • Pre-audit inspections and preparations; cGMP; validation; PIC/s standards implementation and all associated technical activities
  • Assistance with product development and formulation, pipeline planning and production problem solving
  • Strategic project modelling and implementation; Mergers and acquisitions; Manufacturing strategy
  • Co-development opportunities available including new development experience in biosimilars, generic medicines, as well as consumer health and cosmetic projects
  • Product formulation support and trouble-shooting in production processes.
  • Post launch technical project management and pharmacovigilance
  • Patent review and local opinions
  • Trademark advise and application
  • Comprehensive Logistical support framework covering all activities related to artwork generation, variations, launch support, purchase ordering, local testing and release, as well as customs clearance requirements

WHAT ABEX CAN OFFER YOU

  • IP Protection & Management
  • Regulatory Consultancy Services
  • Extedo eCTD software solutions, eCTD consultancy services, training & dossier preparation
  • GMP audit, Technical, & pharmacovigilance services
  • Co-development opportunities
Read More
  • Management and protection of Intellectual Property for key strategic partners
  • Provide complete regulatory services and MCC liaison
  • Product registration applications; Marketing Authorisation management and maintenance
  • Offering electronic Regulatory Affairs solutions, services and training (eg in the eCTD field) to the pharmaceutical industry, as a professional partner of Extedo
  • Pre-audit inspections and preparations; cGMP; validation; PIC/s standards implementation and all associated technical activities
  • Assistance with product development and formulation, pipeline planning and production problem solving
  • Strategic project modelling and implementation; Mergers and acquisitions; Manufacturing strategy
  • Co-development opportunities available including new development experience in biosimilars, generic medicines, as well as consumer health and cosmetic projects
  • Product formulation support and trouble-shooting in production processes.
  • Post launch technical project management and pharmacovigilance
  • Patent review and local opinions
  • Trademark advise and application
  • Comprehensive Logistical support framework covering all activities related to artwork generation, variations, launch support, purchase ordering, local testing and release, as well as customs clearance requirements

“Our offerings are non-conflicting in all aspects”

Anita Smal, ABEX director

Why work with us?

Enjoy the benefits of leveraging from our world class technical and commercial expertise, unparalleled market access solutions, or take a look at our broad range of product offerings covering both prescription and consumer preparations many of which are available as approved Marketing Authorisations

More info

Why work with us?

Enjoy the benefits of leveraging from our world class technical and commercial expertise, unparalleled market access solutions, or take a look at our broad range of product offerings covering both prescription and consumer preparations many of which are available as approved Marketing Authorisations

More info