The right knowledge at the right time saves time and money!


Improved process for oral suspension in late stage pharmaceutical development, original process time was 4 days; process was neither scalable nor robust. Resultant process was scalable and robust with a total processing time of 6 hours. Saved the company $ 32MM.

Successfully managed and coordinated a pharmaceutical technology transfer of a biotech drug-device combination product from a site in Europe to a robotic green field facility in Singapore.

Used Process Excellence (six sigma) approach to reduce the variability associated with the elution test for a drug/device combination medical device. Saved the company $7.8 MM

Successfully used Process Excellence approach to data mine and analysis to resolve an outstanding FDA observation without performing further processing and lab work. Saved the company $ 1.4 MM

Have successfully built technical groups that have supported technology transfers, scale-ups and provided technical support (life cycle management and product support) to products ranging from oral to sterile liquids and semisolid products.

The following table is a list of some of the projects that have been successfully completed over these past 22 years.  No FD 483 were ever received for the work that was performed by our Principal Consultant who participated in these projects.

Compound or Product Combination Product Dosage Form
Peptide Yes Transdermal
Iontophoretic Patch (Peptide) Yes Transdermal
Collagen/Chondroitin Yes Artificial Skin (lyophilized)
Ceftriaxone No Sterile Dry Powder Fill
Cefazolin No Sterile Dry Powder Fill
Cephadrin No Sterile Dry Powder Fill
Adenocard No Vial
Nucleotide (2-CDA) No Vial
Ofloxacin Yes Vial & Prefilled Minibag
L-Ofloxacin Yes Vial & Prefilled Minibag
peptide Yes Vial / Pump
Protein/phospholipids No Multi-laminate Liposome in Vial
3rd generation cephalosporin No Sterile Dry Powder Fill
Perflubron Emulsion No Vial
Haloperidone No Vial
Haloperidone Deconoate No Oil Based in Vial
Intraluken-12 No Vial
Pegylated Interferon No Vial
benzodiazepine No Vial
Exelon Oral Solution No Oral Liquid
Bupivacaine CR Yes Dry Powder Fill of a sterile microsphere
Chirocaine Yes Vial and Prefilled Minibag
Temodar IV No Lyophilized Vial
Redipen Yes Lyophilized syringe (specialty delivery device)
Intron No Lyophilized Vial
Garanoxacin Yes Prefilled Minibag
Noxafil (Posaconazole) No Oral Suspension
Cypher Yes Drug Coated Stent
Cypher Xtend Yes Drug Coated Stent
Cypher Select Plus Yes Drug Coated Stent
Monocryl Plus Yes Drug Coated Sutures