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.


An examination of the effects that the properties of the API have on the powder's processability, the drug's solubility, bioavailability, and stability.

Microdialysis-based IVRT


IVRT studies based on a novel in-vitro technique for complex formulations such as liposomes, injectables, or ophthalmic suspensions.


IVRT investigations for intricate formulations like liposomes, injectables, or ocular solutions that rely on a revolutionary in-vitro methodology.

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.


An assessment of your API's solubility in one or more aqueous mediums that replicate physiological settings and meet sink requirements.

IVPT of Oral Dosage Forms

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.


Bioequivalency (BE) evaluation using in vitro permeation testing. To improve the likelihood that your BE study will be successful, predict IVIVC and rank order formulas.

Method Development


From quickly evaluating the technical feasibility of a method to optimization and executing all required steps for filing a complete finalized method.


From swiftly assessing a method's technical viability to optimising it and carrying out all necessary procedures to submit a fully developed method.

IVPT of Topical Dosage Forms

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.


To assess medication transport into the different layers of the skin and choose formulations for topical and transdermal use, in-vitro permeation testing is used.

In-Vitro Release Testing (IVRT)

Release Testing (IVRT)

Dissolution testing with different apparatus types, methods, automation levels and test setups to determine the most robust method.


Dissolution testing to identify the best reliable approach using various apparatus kinds, techniques, automation levels, and test configurations.


Deformulation /
Reverse Engineering

Reverse engineering to determine the formulation composition of a reference drug for generic pharmaceutical companies.


Reverse engineering is used by generic medication manufacturers to ascertain the formulation composition of a reference drug.

Q3 Characterization


Achieve Q1 / Q2 similarity and perform Q3 characterization to obtain a biowaiver for your complex generic product approval.


Attain Q1/Q2 similarity and carry out Q3 characterization to secure a biowaiver for the approval of your complex generic product.

Analytical Method

Analytical Method

Complete method transfers from manual to automated platforms with comparison studies and final transfer report.


Complete method transfers, including comparison studies and a final transfer report, from manual to automated systems.

IVIVC (In-Silico Simulation)

(In-Silico Simulation)

Develop IVIVC models, evaluate predictability, establish specifications for dissolution, and apply IVIVC as a surrogate for in-vivo bioequivalence studies.


Create IVIVC models, assess predictability, set dissolution requirements, and use IVIVC as a stand-in for in vivo bioequivalency testing.

Cleaning Validation


Analysis of cleaning swabs to develop a robust manual or automated method for regular cleaning validation by the customer.


Analysis of cleaning swabs to provide a reliable manual or automated process for the customer's regular cleaning validation.