Research & Development Services
Our new and a 13,000 sq. ft. science center which includes new state-of-the-art formulation development, QC laboratories and a pilot scale manufacturing operation. The Science Center offers a complete range of drug development services, analytical methods development, methods and process validation, ANDA/NDA product submissions, suitability petitions, raw material and finished product and stability testing. Our well trained staff understands the importance of speed, accuracy, and responsiveness. We provide all the resources necessary to take your product from formulation development to commercial production.
Hi-Tech Pharmaceuticals offers the following services to support your product development requirements:
Analytical Testing
- Methods Development, refinement, & validation
- Raw Material Testing
- Active Pharmaceutical ingredient testing
- Cleaning validation
- Stability testing and storage
- Environmental monitoring and support
- Candidate selection
- Feasibility studies
- Technology transfer
- Process validation
- Clinical supply manufacturing, packaging, and labeling
- Pre-formulation, formulation, and process development of multiple oral dosage forms
- Drug delivery systems
- Regulatory planning and consulting
- Review and counsel on clinical, CMC, and bioanalytical issues
- Submission assembly and preparation
- Planning for and representation at meetings with regulatory authorities
- Agency response preparation
- Regulatory and technical management
- Instrument, equipment, and facility qualification/validation
Our specialty is in providing turn-key solutions to our customer's needs; however we also offer the advantage of selecting services on an individual basis. Our analytical capabilities includes: methods development, refinement and validation, as well as, raw material / A.P.I and stability testing.
Analytical equipment include
- Gas Chromatography (GC)
- (5) High Pressure Liquid Chromatography (HPLC) machines
- (2) UV Spectrophotometers (UV)
- (2) FT-IR Spectrophotometers-the preferred method of infrared spectroscopy
- ICH Stability Chambers
- Dissolution Baths
- A full range of instruments to support full monograph testing
- A full range of instruments to support excipient functionality characterizations
Our product development capabilities include pre-formulation, formulation and process development of multiple oral dosage forms. The department develops tablets and capsules of any dimension with a variety of characteristics such as:
- modified-release
- bi-layers
- pellets
- mini tabs
Development processing equipment include
Solids
- V - Blenders
- High-shear Granulation
- Fluid bed Granulation
- Roller compaction
- Tablets of any dimension
- Bi-layer Tablets
- Film Coating
- Modified Release Film Coating
- Pellet Processing
Liquids
Development equipment train capabilities allows for production of:
- Solutions
- Elixirs
- Suspensions
- Modified Release
- Energy Shots
- RTD’s (Ready to Drink) protein shakes
Our regulatory submission group assists with all aspects of documentation preparation to support your product's application with pertinent regulatory authorities.
Our regulatory services include
- Regulatory planning with our QC and legal staff
- Review and counsel on clinical, CMC and bioanalytical issues
- Submission assembly
- Planning for and representation at meetings with regulatory authorities