• Solid State Characterization

• pH-solubility Profile (as per ICH M9 Guidance)

• Biorelevant Solubility Testing

• Intrinsic Dissolution Rate

• Drug-ability Assessment

•  Micronization of Drug Substance (D90<10 microns)

• Drug Substance - Excipient Compatibility

• Stability and Degradation Evaluation

• Characterization and Reverse Engineering of Reference Listed Drug (RLD) Product

• Biorelevant Dissolution Method Development (USP Apparatus 1, 2, 3)

• Two-stage Dissolution Method Simulating Drug Transfer from Stomach to Intestine

• Troubleshooting on BA/BE Failure and In-vitro-and-in-vivo Correlation (IVIVC)

• Discriminative Dissolution Method Development and Optimization for Quality Control (USP Apparatus 1, 2, 3)

• Dissolution Specification Setup and Justification

• Dissolution Method Development Report and Justification for Biowaiver 

• Justification for Dissolution Method Different from OGD Method

• Dissolution Release Profile Testing

• Patent Landscape Analysis and Formulation Strategy Design

• IND-enabling Preclinical and Toxicity Formulation Development

• First-in-Human (FIH) Clinical Formulation Development

• Immediate Release and Controlled Release Formulations for NDA, Complex Generics, 505 b(2) NDA and New Biological Entity (NBE)

• Solubility and Permeability Enhancement 

• and more!

• Nonclinical regulatory strategy development, including bridging toxicology programs for repurposed molecules e.g., 505(b)(2)

• Study Design, Review of Protocols and Reports 

• Program Development Management

• Toxicology Consultation and Advice, including General Toxicology, Safety Pharmacology, Genotoxicity, Development and Reproductive Toxicology (DART) and Carcinogenicity Studies

• CRO Selection and Study Placement

• Study Monitoring including GLP Auditing

• Literature-based Safety Review and Risk Assessments

• Stability-indicating Analytical Method Development for Raw Materials and Finished Products

• Analytical Method Trouble-shooting and Optimization

• Characterization of Impurity / Degradation Product

• Forced Degradation Study

• Raw Material Evaluation and Potency Determination

• Stability and Photostability Testing for Raw Materials and Finished Products 

• Stability Protocol preparation and approval

• and more!

       Formulation Development

• High Shear Granulator: Freund

• Vector High Shear Granulator

• Roller Compactor: Freund-Vector Roller Compactor 

• Spray Drier: Buchi Spray Drier (for aqueous and solvent)

• Mills: Quadro Comil; Micron Jet Mill

• Blender: Servolift Bin Blender

• Compression Machine: Eliza Tabletting Press (5B+5D, bilayer)

• Tablet Coating System: O’Hara Pan Coater 

• ExpertFill Manual Encapsulation (equivalent to ProFiller 1100)

• Sotax Tap Density Tester

• Sotax Powder Flow Tester

• Sotax Disintegration Tester

• Sotax Hardness/Thickness Tester

• Sotax Friability Tester

• Gilson Sieve Analyzer 

• Sartorius IR Moisture Analyzer

• Polytron Homogenizer
  
  
  Analytical Development
   

• Agilent HPLC 1260 Infinity II (DAD, VWD)

• Agilent GC 7890B with Headspace Autosamplers

• Mettler Toledo UV-Vis Spectrophotometer

• Mettler Toledo Karl Fischer Coulometric and Titrimetric Titrators

• Potentiometric Titrators

• Sotax Xtend Online Dissolution Apparatus (USP 1, 2)

• Sotax Xtend Offline Dissolution Apparatus with Autosampler (USP 1, 2)

• Agilent BIO-DIS Dissolution Apparatus (USP 3)

• Agilent 850-DS Dissolution Sampling Station

• Caron Environmental Stability Chambers

• Memmert Stability Chamber

• Memmert Photostability Chamber 

• Bruker XRD Phaser

• Miele Glassware Washer

• Sartorius micro- and semi-micro Balances

• Sartorius Atrium Water System 

• Beckman Coulter Centrifuge

• VWR Vacuum Drying Oven

• Lab Companion Shaker Water Bath 

• Olympus Polarized Light Microscope

• Branson Sonicator - IKA Shakers