R&D Services –
For your formulation.
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We provide 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. Our unique know-how is based on decades of experience in the development of methods for pharmaceutical products.This understanding encompasses both formulation and analytics, with specific competence in small and big compounds, oral and parenteral modes of administration, and immediate and modified release dosage forms.
Analytical Services
API Screening & Characterization
API Screening
& Characterization
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
Microdialysis-based
IVRT
IVRT investigations for intricate formulations like liposomes, injectables, or ocular solutions that rely on a revolutionary in-vitro methodology.
Solubility Studies
Solubility
Studies
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
IVPT
of Oral Dosage Forms
Bioequivalency (BE) is evaluated using in-vitro permeation testing. Predict IVIVC and rank-order formulas to improve your BE study's success rate.
Method Development
Method
Development
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
IVPT
of Topical Dosage Forms
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)
In-Vitro
Release Testing (IVRT)
Dissolution testing to identify the best reliable approach using various apparatus kinds, techniques, automation levels, and test configurations.
Deformulation
Deformulation /
Reverse Engineering
Reverse engineering is used by generic medication manufacturers to ascertain the formulation composition of a reference drug.
Q3 Characterization
Q3
Characterization
Attain Q1/Q2 similarity and carry out Q3 characterization to secure a biowaiver for the approval of your complex generic product.
Analytical Method
Automation
Analytical Method
Automation
Complete method transfers, including comparison studies and a final transfer report, from manual to automated systems.
IVIVC (In-Silico Simulation)
IVIVC
(In-Silico Simulation)
Create IVIVC models, assess predictability, set dissolution requirements, and use IVIVC as a stand-in for in vivo bioequivalency testing.
Cleaning Validation
Cleaning
Validation
Cleaning swab analysis to offer a dependable manual or automated procedure for the client's ongoing cleaning validation.
Formulation & Development Services
We provide value-added generic products, NCE preformulation, novel formulation concepts for licencing, and the creation of niche generic steriles (US/EU). Our main focus is on liquid oral base products, semi-solid dosage forms, ophthalmic products and injectable drugs. We are adept at working with liposomes, microspheres, depots for in situ gelation and other nanotechnology-based platforms.
- Development of Niche Generic steriles (US/EU)
- Development of Value-Added Generic Products
- NCEs performulation and lead optimization
- Development of New Formulation Concepts for Outlicensing
- Primary focus on injectables, ophthalmics, semi-solids, and liquid oral-based products
- Keen proficiency in liposomes, microspheres in situ gel forming depots and other nanotechnology