R&D Services –
For your formulation.
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Thanks to our unique know-how, based on decades of experience in the development of methods for pharmaceutical products, we offer a wide range of R&D and QC services to help customers overcome the various challenges associated with the development of robust analytical methods in a fully GMP compliant environment. This expertise relates to both analytics and formulation and includes specialized knowledge of small and large molecules, immediate and modified release dosage forms, and oral and parenteral routes of administration.
API Screening & Characterization
API Screening
& Characterization
Analysis of how API characteristics impact on processability of the powder, dissolution of the drug, bioavailability, and stability.
Microdialysis-based IVRT
Microdialysis-based
IVRT
IVRT studies based on a novel in-vitro technique for complex formulations such as liposomes, injectables, or ophthalmic suspensions.
Solubility Studies
Solubility
Studies
Evaluation of the solubility of your API in one or more aqueous media mimicking the physiological conditions and allowing to fulfil sink conditions.
IVPT of Oral Dosage Forms
IVPT
of Oral Dosage Forms
In-vitro permeation testing to assess bioequivalence (BE). Predict IVIVC and rank order formulations to increase the success rate of your BE study.
Method Development
Method
Development
From quickly evaluating the technical feasibility of a method to optimization and executing all required steps for filing a complete finalized method.
IVPT of Topical Dosage Forms
IVPT
of Topical Dosage Forms
In-vitro permeation testing to evaluate drug delivery into the various skin layers and to select formulations for topical and transdermal application.
In-Vitro Release Testing (IVRT)
In-Vitro
Release Testing (IVRT)
Dissolution testing with different apparatus types, methods, automation levels and test setups to determine the most robust method.
Deformulation
Deformulation /
Reverse Engineering
Reverse engineering to determine the formulation composition of a reference drug for generic pharmaceutical companies.
Q3 Characterization
Q3
Characterization
Achieve Q1 / Q2 similarity and perform Q3 characterization to obtain a biowaiver for your complex generic product approval.
Analytical Method
Automation
Analytical Method
Automation
Complete method transfers from manual to automated platforms with comparison studies and final transfer report.
IVIVC (In-Silico Simulation)
IVIVC
(In-Silico Simulation)
Develop IVIVC models, evaluate predictability, establish specifications for dissolution, and apply IVIVC as a surrogate for in-vivo bioequivalence studies.
Cleaning Validation
Cleaning
Validation
Analysis of cleaning swabs to develop a robust manual or automated method for regular cleaning validation by the customer.
