SERVICES
ANALYTICAL TESTING
SERVICES OFFERED
- Genotoxic Impurity Method Development & Validation by LCMS/GCMS
- Chromatographic Method Development & Validation(GC/HPLC)
- Elemental Analysis as per ICH Q3D with Method development and validation by ICPMS.
- Extractable and Leachable studies
- Residual Solvent test By HSGC
- Assay and Related Substances test by HPLC.
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
Analytical Instruments
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
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.
TRADING/SOURCING OF PHARMACEUTICALS RAW MATERIALS, PHARMA INTERMEDIATES & ACTIVE PHARMACEUTICAL INGRDIENTS
AKU PHARMA is a Trader of Active Pharmaceutical Ingredients, API Drug Intermediates and Intermediates Chemicals.
Understanding the importance a team plays in the functioning of a company, we are the team of experience people who are working in close coordination.
If there is any requirement then please feel free to contact us on below given mail id’s
support@akupharma.com ,
akupharmachemicals@gmail.com,
impuritiesatyourdoor@gmail.com,
We have a worldwide contacts to API manufacturers & traders, we can offer API Sourcing support to you. Contact us on above given mail id’s for any API related queries or any specific API you are looking for. We conduct our research worldwide or in the region you prefer. Once we found API manufacturers & traders contacts, we let you know the number of potential producers we found. We charge by the number of addresses we will send you.
TRAINING
We have a training cell to provide the training for the pharma professionals and college students to provide the training on various topics. Some of the topics are given below.
- Mass Spectrometric Techniques & Its Applications
- Elemental Analysis evaluation as per ICH Q3D
- Method Development & Validation.
- Analytical aspects for Regulatory Filing
- Nitrosamines Impurities & its Control Strategy
- Chromatography application in pharma world
- Spectroscopy Applications
Also, our analytical expert team arranges off-site and onsite training based on the clients requirements as and when required .
CONSULTANCY
Our expert and experienced team members provide consultancy services on various subjects as per given below .
- Analytical lab consultancy
- Analytical instrument evaluations
- Analytical assistance in DMF filing.
- Assistance in regulatory Filing
- Quality Assurance assistance for lab set up
IMPURITIES/WORKING STANDARDS SUPPLY
We are the trusted pharmaceutical impurity standards suppliers & Manufacturer in India.
Our strength is well experience team of scientists who conduct several challenging synthesis as well as solve problems that arise in the synthesis process. Also we can do multi step synthesis.
So kindly reach us with your requirement on below given mail id’s
- support@akupharma.com ,
- akupharmachemicals@gmail.com,
- impuritiesatyourdoor@gmail.com,
HUMAN RESOURCE SERVICES
We have an agreement in place with pharma companies for man power recruitment. We are helping our pharm client to appoint appropriate and suitable candidate for the particular role. Many CV’s are available in our data base related to pharmaceutical manufacturing, Quality control, R&D & ADL dept.
We are happy to serve the client to the best of their ability, which makes AKU pharma the number one choice for the human services for many pharma clients.
THIRD PARTY MANUFACTURING
Third party or contract manufacturing is referred to the outsourcing of pharmaceutical products or to get products manufactured from others manufacturing units with your own brand names.
In the current time, it is a very popular strategy among all the marketing companies.
We are taking formulation and active pharmaceutical manufacturing/Intermediates projects as a third party manufacturing.
If there is any requirement then please feel free to reach us.
support@akupharma.com
OUR PHARMA CLIENTS
