ABOUT AKU PHARMA
AKU PHARMA is a team of analytical expert team, established in 2018. AKU PHARMA is in the business of providing various services to pharmaceutical, chemical industry.
AKU PHARMA is situated in the heart of the Thane city. We are counted among the reliable service providers in this sphere.
Our experienced teams of people are able to do all analytical task in accordance to prevailing quality norms.
And so, clients get the best Analytical solutions from us.
ANALYTICAL TESTING SERVICES OFFERED
- Chromatographic Method Development & Validation(GC/GCMS/HPLC)
- Assay and Related Substances test by HPLC.
- Elemental Analysis with Method validation or Heavy metal testing by ICPMS.
- Residual Solvent test By HSGC
- Genotoxic Impurity Method Development & Validation.(GCMSMS & HSGCMS)
- Extractable and Leachable studies
- Spectroscopic Analysis.(IR and UV Visible Spectroscopy).
- Total Organic Content(TOC Analysis)
OTHERS TESTING SERVICES OFFERED
- Impurity profiling analysis by liquid Chromatograph Mass Spectrometry and interpretation of data.(LCMS)
- Impurity profiling analysis by Gas Chromatograph Mass Spectrometry and interpretation of data
- X-ray powder diffraction analysis (XRPD)
- Thermal Gravimetric Analysis (TGA)
- Differential scanning calorimetric (DSC)
- Nuclear Magnetic Resonance Spectroscopy analysis and interpretation of data(NMR).
- Physiochemical properties like Partition coefficient and dissociation constant (pK & PC) determination.
- Structural Genotoxicity evaluation/prediction by Software as per ICH M7(R1) guideline
- CHNS-O-Chloride elemental analys
- Scanning electron microscopy (SEM)
- Energy Dispersive X ray Spectroscopy (EDS)
- SEM-EDS
- Particle size analysis(Wet and Dry powder method)
- Impurity isolation by preparative HPLC
- Specific Optical Rotation
- PDE Calculations
- Total Organic content by TOC analyzer
REGULATORY SERVICES:
AKU PHARMA provides the following services to pharma clients
DMF compilation
- Dossier compilation
- CTD/ACTD Dossier
- Dossier for Regulated market
- Dossier for ROW market
- Dossier for Herbal products
- Dossier for Nutraceutical products
- DMF for Excipient
- DMF for Packaging material
For enquiry and charges details kindly email us on support@akupharma.com
AKU PHARMA is aware that many small scale manufacturers are either not having facilities conducting analysis or conducting many specialized Study. AKU PHARMA is having very good analytical facility for performing all kind of analytical services for supporting Regulatory affairs functions and documentary support.
Services and Products:
DMF Compilation Services: AKU PHARMA is having expertise in compilation of Drug Master File for different Countries.
Dossiers for Asian Countries (ACTD) : AKU PHARMA is having specialized team for compilation of ACTD Dossier. We are accepting task for compilation of ACTD Dossier for all Asian Countries.
Dossier Compilation CTD Format: Compilation of Pharmaceutical Dossier in CTD Format for US, Europe and some other Countries is also an area of expertise for AKU PHARMA
Dossier Compilation for ROW Market (Rest of the World Market): AKU PHARMA is having expertise for compiling dossiers for rest of the world market. AKU PHARMA has compiled Dossiers for many countries like Kenya, Sri lanka, Tanzania, Philippines … etc
OUR PHARMA CLIENTS
