Sample Testing
As part of their research and development efforts, drug development personnel use analytical services laboratories to determine a chemical compound’s chemical and biological properties, which they can then develop and enhance. Both the safety profile and the therapeutic or health effects of a drug candidate can be assessed through these testing services.
- Fourier Transform Infrared Spectroscopy (FTIR)
- Nuclear Magnetic Resonance (NMR)
- X-ray Fluorescence Spectroscopy (XRF)
- Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES-MS)
- Ultraviolet visible Spectroscopy (UV-Vis)
- Colorimetric Analysis
- X-Ray Diffraction Spectroscopy (XRD)
- Raman Spectroscopy
- pH evaluation
- Particle Size Counter for Injectables
- Dissolution
- Disintegration
- Hardness
- Friability
- Zeta potential testing
- Particle Size Testing
- KF AutoTitrator-Moisture Content Determination
- Scanning Electron Microscopy
- Transmission Electron Microscopy
- Thermogravimetric Analysis or Thermal Gravimetric Analysis (TGA)
- Thermogravimetric and Differential Thermal Analysis (TG-DTA)
- Thermomechanical Analysis (TMA)
- GC/MS/MS)
- LC/MS/MS
- Gas chromatography–mass spectrometry (GC-MS)
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Liquid chromatography–mass spectrometry (LC-MS)
- High Performance Liquid Chromatography (HPLC)
Formulation Research & Development
A major part of FDC’s growth strategy is formulation research. Formulation is responsible for designing and developing simple and complex dosage forms for domestic and international markets. Highly specialized technology is used to create niche products.
The R & D Centre is divided into two departments:
Formulation Research & Development [FR & D]
Analytical Research & Development [AR &D]
Our R & D is equipped to conduct the following processes for Formulation Development :
Product and process optimization
Analytical method development
Analytical method validation
Evaluation and techno-marketing studies
Technology transfer
Analytical & Development
Pharmaceutical analysis is traditionally defined as analytical chemistry dealing with drugs both as bulk drug substances and as pharmaceutical products (formulations). However, in academia, as well as in the pharmaceutical industry, other branches of analytical chemistry are also involved, viz. bioanalytical chemistry, drug metabolism studies, and analytical biotechnology.
- Development and validation of UV/ HPLC/ UPLC Assay method for Active Pharmaceutical Ingredients /formulations.
- Development and validation of HPLC/ UPLC analytical method for determination of enantiometric content in Active Pharmaceutical Ingredients /formulations
- Impurity profiling for Active Pharmaceutical Ingredients /formulations
- Stability Studies for Active Pharmaceutical Ingredients /formulations
- Determination of quantity of drug from biological samples by HPLC / UPLC / LC-MS
- Development and validation of UV/ HPLC/ UPLC Analytical method for quantification of preservatives in formulations
- Development and validation of UV/ HPLC/ UPLC Analytical method for content uniformity in formulations
Contract Manufacturing
All pharmaceutical contract manufacturers must adhere to FDA good manufacturing practices and comply with applicable FDA regulations. In addition to pharmaceutical contract manufacturers, known as CMOs, there are other business models that handle the outsourcing needs of pharmaceutical companies such as that of drug development, pharmaceutical manufacturing, research and testing:
- Drug Development
- Drug Manufacturing & Commercial Production
- Documentation of Compliance with FDA Regulatory Requirements
- Pre-Formulation
- Development of Drug Formulation
- Conduction of Stability Studies, method development, pre-clinical, Phase I Clinical Trials
- Providing formal Scale up, Stability & Registration Batches
Dossiers
“Registration Dossier” of the pharmaceutical product is a document that contains all technical data (administrative, quality, nonclinical, and clinical) of a pharmaceutical product to be approved / registered / marketed in a country.
Pharmaceutical Patent Services
The company has a number of professionals with advanced degrees in chemistry and life sciences that prepare and prosecute patent applications. In addition to small molecule pharmaceuticals, biopharmaceuticals, bioinformatics, personalized medicine, polymorphs and pharmaceutical formulations, our attorneys and patent agents have drafted and prosecuted patent applications. In case of patent office or regulatory agency delays, we can also help you obtain patent term extensions.
Trainings/Workshops
We are ISO Certified organization for Training & Workshops. Bring about change that drives improvements at SS Pharma Labs – Pharmaceutical Training & Education programs focus on changing behaviour at both an individual &organization wider level.