PharmaLogic Development, Inc. provides services to the pharmaceutical and biomedical industries through the drug development process. In planning the optimum usage of resources, skills, and commercially available resources, our support ranges from candidate selection through NDA, to marketing support.
Development Services
Accomplishments
Key Roles
Development Services
PRIMARY THERAPEUTIC AREAS
Ophthalmology
Dermatology
Neurology
REGULATORY
NDA/Preclinical and clinical reports & summaries
FDA client representation (pre-IND, pre-NDA meetings)
Literature Reviews
CLINICAL TRIALS
Clinical Trial Outlines
Protocol Design
Biostatistical Evaluation
Medical Final Reports
PRODUCT RESEARCH AND DEVELOPMENT
Preclinical Data Review
Candidate Selection
Licensing Representation
Business Plans
IND Preparation
Scientific/Medical Abstracts & Posters
Public Presentations
Focus groups
Competitor Intelligence
Overview
Accomplishments
As we reflect back on our more than 30 years, some of our key accomplishments are:
Some of our key accomplishments are: Played a key role in the development of over 40 ophthalmic, dermatologic, and neurologic approved products
NDA Firsts: First treatment for macular degeneration, First soft drug, First and second intravitreal drug delivery system
Served over 400 clients in four continents on thousands of projects
Contributed to over 100 IND and IDE submissions
Organized and lead clients on scores of meetings with regulatory agencies worldwide
Serving as a director of a publicly traded ophthalmic pharmaceutical firm, including raising over $100 million in financing
Served as agent for a multi-million dollar licensing arrangement
Created several business plans, including one funded at over $80 million
Had our 225th paper accepted to a peer-reviewed journal
Published over 60 additional papers as medical writer, plus others as editor for non-English speakers
Performed 100’s of literature and patent searches, including support for patent arbitration
Key Roles
List of products on which PharmaLogic has made major contributions:
Acular® (Ketorolac)
Acuvue® with Ketotifen
Alamast® (Pemirolast)
Alomide® (Lodoxamide)
Alphagan® (Brimonidine)
Alrex® (Loteprednol etabonate)
Aquaflow
Array® Multifocal IOL
AzaSite™ (Azithromycin)
Azopt® (Brinzolamide)
Bepreve™ (Bepotastine)
Besivance™ (besifloxacin)
Betagan®, Mirol® (Levobunolol)
Betaseron® (Beta-1b interferon)
Betoptic-S® (Betaxolol)
Bion Tears®
Botox® (Botulinum toxin type A)
Buphenyl® (Sodium phenylbutyrate)
CellCept (Mycophenolate mofetil)
Cequa® (cyclosporine)
Chibroxin® (Norfloxacin)
Clindagel® (Clindamycin phosphate gel)
Differin® (Adapalene)
Durezol® (Difluprednate)
FML-Forte ® (Fluorometholone)
Istalol(® (Timolol maleate)
iStent™
Keracor 11
Jetrea® (ocriplasmin)
Kyprolis® (carfilzomib)
Lotemax® (Loteprednol etabonate)
Luxiq® (Betamethasone valerate foam 0.12% )
Myobloc® (Botulinum toxin type B)
Myrbetriq® (mirabegron)
Ocufen® (Flurbiprofen)
Ocupress® (Carteolol)
Omidria® (phenylephrine/ketorolac)
Optipranolol® (Metipranolol)
Optivar® (Azelastine)
Paxene® (Paclitaxel)
Rescula® (Unoprostone isopropyl)
Restasis® (Cyclosporine)
Retisert® (Fluocinolone acetonide)
Rhopressa® (Netarsudil)
Rocklatan (Netarsudil/Latanoprost)
RxSight Light Adjustable Lens
Technolas Laser
Travatan® (Travoprost)
Trusopt (Dorzolamide)
Verkazia™ (Cyclosporine)
Visudyne® (Verteprofin)
Vitrasert® (Ganciclovir)
Vitravene® (Formivirsen)
Xiidra® (Lifitegrast)
Zaditor® (Ketotifen)
Zanaflex® (Tizandine)
Zylet® (Loteprednol etabonate/tobramycin)
PharmaLogic has built its reputation on the following principles: