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Development
RESEARCH & DEVELOPMENT
Development of products using the most contemporary methods and modern equipment along with robust process guidelines.
Product Development
Hibrow's R&D lab is a state-of-the-art facility equipped with end-to-end unit operation line catering to different Pharmaceutical processes that suits every individual project-specific designs and requirements.
Equipment line-up
- Micronizer
- High Shear Mixer Granulator
- Roller Compactor
- Fluid Bed Processor / Dryer
- Tray Drier
- Cizer Mill
- Double Cone Blender
- Tablet Press
- Tablet Imprinting Machine
- Capsule Filling Machine
- Fully Perforated Coating Machine
- Precision Powder Filling Machine
- Bottle Packing Machine
- Blister Packing Machine
Analytical Development
The analytical development team expertizes in developing the latest analytical methods, keeping in mind our futuristic needs in order to avoid major changes during technology transfer such as changes in instrument models.
Following is the major instrument line-up in Analytical Development
- High Performance Liquid Chromatography.
- Ultra High Pressure Liquid Chromatography.
- Gas Chromatography.
- UV-Visible Spectrophotometer.
- Dissolution Apparatus - Autosampler Enabled.
- Fourier Transform Infrared Spectrophotometer.
- Particle Size Analysis By Laser Diffraction (Malvern Mastersizer).
- Powder X-Ray Diffractometer.
- Differential Scanning Calorimetry.
- Atomic Absorption Spectrophotometer.
Technology Transfer
We offer technology transfer support to developed and approved formulations. Our in-depth analysis and core assessment include risk assessment and gap analysis.
We provide fully-developed products that can both be manufactured in our site or at an alternate site as per our clients' convenience.
The technology transfer support provided will be as follows
- Formulation Development
- Analytical Development
- Gap Analysis
- Risk Assessment
- Queries Handling
- Guidance to specific product requirements
- Bioequivalence Monitoring
- Quality system assessment of the facility
Project Management
We have an effective project management procedure in place to provide
- Detailed project status
- Timely completion of the project
- Effective communication with client and other stakeholders
- Robust follow ups at each stage
- Managing the project at cost effective manner
Bioequivalence Monitoring
We provide monitoring support on bioequivalence studies using our in-depth knowledge of formulations and in-vitro performances. We also equate the 'bioequivalence study design' and provide review of the study data.
Regulatory Affairs
Our regulatory personnel provide support on the following:
- Compilation of ANDA
- Review of documents to be submitted in ANDA
- Provide GAP analysis on Submitted/under submission ANDA
- Provide support on site transfer submissions
- Review of DMF
- Query response to the regulatory agency
- Post approval support to ANDA