SPS Pharma Services

Specialized in in vitro dissolution testing,  SOTAX Pharma Services team has a proven track record of finding the most suitable method for products ranging from APIs and tablets to implants, semi solids, and many more. Set in a US FDA-inspected facility, with a cGMP-compliant environment with strict quality management processes, the scientific expertise of SOTAX staff paired with state-of-the-art instrumentation ensures best in class services and ease of regulatory compliance for customers. 

Core Competencies

Inter-disciplinary needs.

Understanding inter-disciplinary needs is at the very heart of our Pharma Services. Specialized in dissolution testing, our experts are familiar with the various challenges associated with governing norms & regulations, different analytical methods to analyze samples, developing a robust method, differently automated instrumentation, API characterization, routine testing, stability testing, and more. With results being affected by API properties, formulation composition, manufacturing process or predicting biopharmaceutical performance, it requires a strong understanding of these various fields to utilize its complete potential.

Empower your Dissolution.

Dissolution has gained significance because of its importance as a Critical Quality Attribute (CQA), a major surrogate for pharmacokinetic performance and bioavailability. It is used throughout the product lifecycle, from discovery of the active molecules and their selection until marketing of the drug product and post-approval monitoring.

An understanding of the mechanisms of dissolution constitutes a prerequisite for proper Quality by Design product development.

SOTAX's know-how about both pharmaceutical dosage forms and release testing techniques enable SOTAX Pharma Services to offer customized development strategies to fulfill the requirements of its clients, making sure that the developed method fits the intended purpose: formulation screening, IVIVC, or Quality Control.

SOTAX Pharma Services

R&D Services

• API screening and characterization
• Reverse Engineering / Deformulation
• Q3 characterization (physico-chemical)
• In Vitro Release Testing (IVRT, USP 1-7)
• In Vitro Permeation Testing (IVPT) for topical dosage forms
• In Vitro Permeation studies for oral dosage forms for BE assessment
• Novel microdialysis based IVRT studies
• Feasibility studies for methods
• IVIVC (in silico simulation, modelling)
• Analytical method automation
• Analytical method development
  (dissolution, LC-RI-ELSD, GC-HS, LC-MS, IC)

Routine Testing Services (GMP)

SOTAX Pharma Services offers routine GMP testing including associated services in a US FDA-inspected facility. Our fully cGMP-compliant environment and proven scientific knowhow in combination with modern lab equipment provide first class services and 100% compliance.

• Analytical Method Validation and Method Transfer
• In Vitro Bioequivalence
• QC analysis
• Stability studies
• LC/MS Testing for Impurities, Nitrosamine
• Clinical & Commercial batch release

Support Services

Whether you need to identify possible causes and solutions for your specific problem throughout the product lifecycle or need to review analytical and clinical data from a failed bioequivalence for troubleshooting in order to de-risk the next steps of development, our unique knowledge based on decades of experience and interactions with health agencies can provide valuable help for your specific problem. 

• Troubleshooting and investigations
• Training
• Consulting
• Audits
• Support for Q1 / Q2 regulatory clearance

Applications

SOTAX Pharma Services provides clients with knowledge, research and testing for all types of dosage forms. From solid oral products like tablets and capsules to many other dosage forms such as microspheres, liposomes, injectable suspensions, ophthalmic suspensions, coated medical devices (e.g. stents), creams, gels and implants.