Our formulation laboratories are fully equipped for development of any product from NCEs to generics including specialty products and oncology product development. We also specialize in reformulation and life cycle extension of existing molecules. We develop effective and efficient products within the committed timelines by utilizing process analytical technologies (PAT)
Preformulation
Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules
Preformulation Services:
Polymorph screening and selection
Salt form selection
Crystalline properties
pH solubility and stability
Solid-state and solution-state stability
Photostability
pKa and partition coefficient determination
Hygroscopicity
Morphology assessment
Solubility studies
Intrinsic dissolution
Excipient compatibility
Leachables and Extractables studies
Flowability
Particle size determination by laser lights
Container – active pharmaceutical ingredient (API) interactions
FT-IR (A Fourier Transform Infrared) spectrometer Capillary Electrophoresis
SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscope)
Potentiometer
Hot-stage Microscopy
Laser light diffraction Particle size analyzer
Intrinsic dissolution
Head Space GC analyzer
ICPMS (Inductively Coupled Plasma Mass Spectrometry)
IC (Ion Chromatography)
Zeta sizer
Malvern particle size analyzer
AAS (Atomic Absorption Spectroscopy)
Formulation development
Our scientists use Quality-By-Design (QbD) tools at all stages of formulation development. Design of experiments (DOE) along with risk assessment strategies allows us to design our experimental plan. Our development approach allows us to meet our delivery timelines and helps us in providing our clients with cost-effective drug delivery solutions
Analytical research and development (AR&D) offers standalone services and supports our formulation development activities. The AR&D teams are integrated with preformulation, product development and quality assurance teams to ensure effective and accelerated product development. Our experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities
Analytical services
Method development
Method validation
Method qualification
Method transfers
Stability studies including zone IV studies
Chiral analysis
Microscopy
Microbiology
We offer a wide range of compendial and non-compendial testing services. Our microbiology laboratories are designed to facilitate in-house studies as well standalone testing services for our clients.
Services
Microbial Limit test
Antimicrobial Efficacy test
Environmental Monitoring
Water chemical and microbial analysis
Bacterial endotoxin test
Antibiotics and vitamins assays
Raw materials/excipients analysis as per BAM (Bacteriological Analytical Manual)
Offsite storage of data for disaster recovery and business continuity
Experience of Proof of concept studies, Patient PK Studies, Food Interaction Studies, Clinical end point studies and Clinical Trials
Volunteer database
Male: 8000+
Female: 2000+
Access to post-menopausal women database
Bio analytical Services
Our Bioanalytical laboratory is equipped with state-of-the art Liquid Chromatography and Tandem Mass Spectrometry (LC-MS/MS) instruments with a capacity of 4000 samples per week. Our highly qualified team of scientists with in-depth knowledge in instrumentation and application of LC-MS/MS technology enables timely method development. We validate our analytical methods as per global regulatory requirements and we follow applicable GLP guidelines.
Our scientists have derived a process flow that generates results with quality withstanding any regulatory scrutiny while meeting your timelines. With a proven track record in developing methods for highly complex (hormones) and unstable molecules, we are your right partner for all your bioanalytical needs.
We currently perform bioanalysis on the following LC-MS/MS: