Skip to content
Contact us

Pharmaceutical Product Development

Our unique and efficient approach to formulation development can quickly turn your API into a fully formulated and tested product ready for clinical trials.

Our services:

Our formulation development services capabilities

  • Immediate, orally disintegrating, modified, delayed, extended release and controlled-release tablets and capsules
  • Over-encapsulation for double-blind studies
  • Bioavailability enhancement
  • Highly-potent compounds
  • DEA controlled substances (Schedule I-V)
  • Combination of multiple APIs
  • Matching placebo (solid, semi-solid and liquid dosage form)
  • Powder/blend filling in bottles, vials and pouches using automatic filling machine
  • Drug layering and particle coating (Wurster column and top spray coating processes)
  • Liquid in hard gel capsule and banding/sealing
  • Solution, suspension, powder for reconstitution
  • Tablet, capsule and pellet coating
  • Semi-solid and topical formulation development

Our formulation development services and analytical testing capabilities can prepare your innovations for Phase I in as little as four weeks. We know what it takes to get your product into clinical trials, evaluating critical quality attributes (CQAs) from R&D to GMP manufacturing.

We treat your formulation as our own, working closely with you to overcome challenges and optimize your product for a wide range of dosage forms. Our time-tested approach has flexibility built in, backed up by our robust quality-by-design framework, to maximize efficiency and minimize risk.

With Sharp, you get a partnership shaped around you. We are committed to protecting your innovation and supporting you to the next stop on your journey, clinical trials.

Our analytical and research & development teams use advanced investigative technologies to provide clients with the innovation required to move a product from clinical development to commercialization and ultimately to patients. 

Pre-Formulation Services

  • Excipient-API compatibility studies
  • Formulation evaluation using accelerated/stress conditions (e.g. 40°C/75%RH, 50°C)
  • Hygroscopicity studies
  • Photostability
  • Prototype evaluations
  • Reverse engineering

Formulation Development Services

  • Early to late phase formulation development and reformulations
  • Determine blending times for tableting, encapsulation and analysis of characteristics (blending time, bulk density, content uniformity and flow characteristics)
  • Over-encapsulation and comparator product blinding
  • Developing matching placebo products and comparator supplies
  • Developing both ethical and over-the-counter (OTC) products, including tablets (immediate and controlled release), powders, liquids, suspensions, emulsions, creams, ointments and lotions
  • Developing line extensions in the above dosage forms

Technical Capabilities

  • Immediate, orally disintegrating, modified, delayed, extended release and controlled-release tablets and capsules
  • Over-encapsulation for double-blind studies
  • Bioavailability enhancement
  • Highly-potent compounds
  • DEA controlled substances (Schedule I-V)
  • Combination of multiple APIs
  • Matching placebo (solid, semi-solid and liquid dosage form)
  • Powder/blend filling in bottles, vials and pouches using automatic filling machine
  • Drug layering and particle coating (Wurster column and top spray coating processes)
  • Liquid in hard gel capsule and banding/sealing
  • Solution, suspension, powder for reconstitution
  • Tablet, capsule and pellet coating
  • Semi-solid and topical formulation development

Technical/Analytical Services

  • Evaluating commercial products for use in clinical trials and comparative studies
  • Formulation optimization and evaluation of excipients for use
  • Technical transfer from R&D to clinical production facilities
  • Process optimization
  • Scale-up and assessment of current products
  • Blend and content uniformity evaluation
  • Dissolution testing
  • Stability assessment
  • In-vitro dissolution profile evaluation
  • Powder flow determination
  • Tablet compressibility evaluation
  • Disintegration testing
  • Friability testing
  • Tap density testing
  • Particle size testing

Clinical Services Inquiry

Would you like to find out more about our clinical services? Fill the form below so we know what area you’re interested in and we’ll be very happy to help.

"*" indicates required fields

What service area are you interested in?
How did you hear about us?

[1]Sharp takes your privacy seriously and will only use your personal information to provide services that you have requested from us. We will not share your personal information with non-agent third parties. View our privacy policy here

This field is hidden when viewing the form
This field is hidden when viewing the form
This field is hidden when viewing the form
Contact Rob Feltz

To find out more about Pharmaceutical Product Development, please contact: Robert Feltz, Director of Analytical and Formulation Services

Our experience is your strength
Contact us