BA/BE studies:
PHASE-1:
Our aim is to provide quality service to the pharmacy market by conducting quality bioavailability, bioequivalence, safety and tolerability studies both efficiently and economically at a Good Clinical Practice (GCP)/Good Laboratory Practice (GLP) compliant center.
KPGC understands the unique demands and requirements of fast paced Phase I BA/BE research and its nuances globally.
An experienced and dedicated team of can help you facilitate rapid turnarounds while maintaining the utmost quality in research participant protection, reliability, and service.
CLINICAL TRIALS(PHASE 2- 4):
We are ready to partner with clients on developing an entire program or applying expert resources to a specific study or function.
Our services are given below:
- Protocol development
- Protocol feasibility
- Project management and planning.
- Medical monitoring
- Clinical monitoring
- Data management
- Biostatistics
- Medical writing
- Regulatory affairs
- Drug safety
- Quality assurance
Formulation development:
We can help you with particular emphasis on development of drug delivery systems and sustained or controlled release dosage forms
FORMULATION RESEARCH & DEVELOPMENT
Our services include but not limited to
- Solutions and suspensions
- Capsules and tablets
- Gels and ointments
- Liposomes and emulsions
- Sprays and creams
- Proteins, peptides, nucleic acids, insoluble compounds
- Formulating, sterilization, stability testing
- Packaging selection, identification or problem resolution
KPGC can support your organisations by supplementing our expertise to determine efficient processing conditions to meet your product goals.
Contract manufacturing:
- Oncology (Anti Cancer Injectables)
- Pre-Filled Syringes
- Antibiotics & Anti-Infective
- New Molecules (FDC)
- Liquid Ampoules / Vials
- Biological Injections
- Cardiovascular Injections
- Neurology
- Other Injectables
- Hormones
- Eye/ Ear/ Nasal Drops
Reference product suppliers:
As a drug company seeking approval to market a generic equivalent must refer to the RLD in its ANDA , We can help you procure the required reference products, which is required for Bioequivalence.
We provide the RLDs with utmost quality and also maintaining the timelines.
