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 nutritional development services for solid dose, powders and liquids. We also provide analytical methods development, methods and process validation, NDI product submissions, 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 Nutraceuticals offers the following services to support your product development requirements:

• Analytical Testing
  
• Methods Development, refinement, & validation
  
• Raw Material Testing
  
• Cleaning validation
  
• Stability testing and storage
  
• Environmental monitoring and support
  
• Process validation
  
• Pre-formulation, formulation, and process development of multiple oral dosage forms

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 and finished goods 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

• Since the passage of the Dietary Supplement Health and Education Act in 1994, regulatory compliance has become increasingly complex. And for those seeking to market dietary supplements abroad, it can be difficult to keep abreast of ever-changing regulations. Our knowledgeable Regulatory Affairs and Information Services team can provide valuable assistance to help you to avoid costly errors. We offer the following services, at no extra charge:
  
• Full label review of products to be distributed in the USA – ensures accuracy and regulatory compliance
  
• International registration assistance — we provide and coordinate all required documentation in a timely manner
  
• Formula modifications — we will work with your international consultants to adapt your formulas to the requirements of each country
  
• Full service testing, including microbiological and stability studies