Accesskey Navigation

Log-in

If you aren't registered yet, please click here.

User login

Stay logged in

Reset your password ###settings.clickhere###

Content

R&D
Services.

SPS Pharma Services offers unique knowledge based on decades of experience in developing in-vitro methods for pharmaceutical products. Such knowledge is related to both analytics as well as formulation and includes expertise for small and large molecules, immediate or modified release dosage forms, oral and parenteral routes of administration.

Method automation

  • Assessment of method transfers to automated platforms for dissolution and sample preparation
  • Complete method transfer from manual to automated platforms with comparison studies and final transfer report

Feasibility studies

  • Selection of the most suitable method for your application by testing possible candidates & first formulations
  • Comparison of all compendial dissolution methods described in Pharmacopeias (US, EU, JP, etc.)

Method validation & re-validation

  • Validation of new methods and revalidation of existing methods with clearly defined protocols as well as detailed validation reports
  • Post-marketing re-testing (SUPAC, lifecycle management, etc.)

Method
development

  • Optimization of the operating parameters to achieve a robust, validatable, and acceptable method
  • Understanding of the authorities’ expectations with regards to method justification
  • In-vitro pharmaceutical equivalency testing

API screening & characterization

  • Comparison of API sources and supply chain assessment
  • Identification of possible first candidates
  • Intellectual property protection for new chemical entities

Method transfer

  • Complete analytical method transfer from R&D to QC or from site to site
  • Preparation of transfer protocols with clearly defined acceptance criteria, comparison studies, and final transfer report

Routine
Analytical
Services.

SPS Pharma Services is an established organization able to fulfill the need of its clients for a one-stop solution from method development to routine GMP testing. This complete solution minimizes the risks inherent to method transfers.

QC analysis

  • Dissolution testing using all compendial techniques
  • Assay and degradation products
  • UV / HPLC / UPLC testing
  • Physical testing (hardness, disintegration, etc.)

Stability studies

  • Secured storage conditions with automatic alarms to staff (24/7) and generator backup
  • Supportive or registration stability testing in every phase of drug development
  • Periodic stability testing of your commercial products

Clinical & commercial batch release

  • GMP certified Pharmaceutical Establishment
  • Commercial batch testing using validated methods
  • Batch release for Europe by our Qualified Person

Support
Services.

Dissolution has become crucial because of its power as a tool, when properly used, to help better understand and control a products’ properties. Its ability to monitor the overall product quality makes it an asset for the Quality by Design (QbD) approach.

Troubleshooting &
Investigations

  • Identification of possible causes and solutions for your specific problem throughout the product lifecycle; from research and development to manufacturing of commercial batches

Audits

  • Quality audits of manufacturing and testing contractors
  • Technical analytical data audits

Consulting

  • Review of analytical and clinical data from a failed bioequivalence for troubleshooting in order to de-risk the next steps of development
  • Support for the handling of OOS (out-of-specification) results to identify the root cause (product or method issue)

Training

  • Best practices of dissolution testing
  • In-vitro dissolution methods development
  • Dissolution testing for non-conventional dosage forms
  • Dissolution testing using non-conventional dissolution techniques
  • IVIVC (in-vivo in-vitro correlations)
  • GMP implementation