Finished dosage forms – Development services

Responsive solutions… through our scope of service

Our experienced finished dosage form development team are experts in developing drugs creatively. We can work with you to overcome even the most complex challenges, ranging from improving patient compliance to expanding indications. The Saneca Pharma team can support novel formulation development or generic substitution.

Saneca Pharma´s  track record is one  you can trust. Our finished dosage form development team has successfully created numerous control release and extended release formulations,  successfully ensuring afterward  rapid scale up to full production. Saneca  supports customers in  developing:

  • Tablets (bilayer, film coated, effervescent, chewable)
  • Hard gel capsules
  • Soft gel capsules
  • Multiple unit systems (microspheres, pellets)

Our capabilities
Saneca Pharma´s finished dosage form development services include:

  • Galenic development (screening, pre-formulation and lab scale development)
  • Analytical method development, verification and validation
  • Stability testing
  • Production and release of clinical trial material (investigational batches)
  • Product transfer
  • Process validation
  • Preparing  registration dossiers and manufacturing documentation
  • Experience in drug marketing authorisation in many countries

The Saneca difference

There are a number of factors that set our finished dosage form development services apart.

  • We take a modern, systematic approach toward development,  designing of experiments and stress quality in design and in-vitro in-vivo correlations
  • We have the capability to scale-up your product on one site from pilot to commercial production, simplifying your journey to project success
  • Our analytical department is equipped to use separation techniques and dissolution methods, including GIT simulation (pH exchange, transit times)
  • We have the processes and safety knowledge to handle dosage forms for  controlled drugs up to schedule II
  • We have the expertise to develop products with novel release mechanisms (rapid, immediate and modified)
  • Our innovative techniques such as taste making , oral disintegration and hot melt technology can overcome your complex challenges

If you would like to find out more about our finished dosage form development services, please contact us.

Image gallery

Did our portfolio meet your needs? Let´s discuss starting business with us.

Contact us