rob-feltz

To find out more about Contract Manufacturing, please contact:

Robert Feltz, Director of Analytical and Formulation Services

We offer a wide range of scalable contract development and manufacturing capabilities for diverse and complex dosage forms including: Immediate release tablets and capsules, Controlled release (CR), extended release (ER), and modified release (MR) tablets and capsules, Mini tablets, Fixed dose combination products, and Powder and Spheres in sachets.

Our experts maintain the integrity of your double-blind studies with the design, development and manufacture of placebos and trial doses that match your drugs and existing comparators.

Supporting phase I-IV development and reformulations, our GMP manufacturing teams are supported by integrated IND-enabling research and development services, including analytical, pre-formulation and formulation services. 

Solid Oral Dose Solutions

Our teams have extensive experience in developing various dosage forms for challenging small molecules, highly potent compounds, and even DEA controlled substances (Class I through Class V). Our capabilities include:

  • Blending
  • Granulation
  • Coating
  • Compression
  • Encapsulation
  • Over-encapsulation
  • Immediate release tablets and capsules
  • Controlled release (CR), extended release (ER), and modified release (MR) tablets and capsules
  • Mini tablets
  • Fixed dose combination products
  • Powder and Spheres in sachets

Liquids and Semi-Solids

  • True Solutions
  • Nasal Sprays
  • Powders for reconstitution/suspension
  • Gel formulations

Sterile fill-finish: isolator-based sterile filling capabilities

Sharp offers clinical scale isolator-based sterile filling of syringes, vials and cartridges via our partnership with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM). 

Isolator-based filling technology removes the risk of human contamination from the formulation and filling process. 

Sharp also provides global comparator sourcing, procurement, and blinding to ensure the scientific credibility of your clinical trial.

With commercialization in mind, our drug development and GMP manufacturing services help you achieve optimum results for your clinical trial and commercial scale-up.