HOW DO YOU ADJUST A FORMULATION FOR TIMED RELEASE? HOW DO YOU MAKE A DRUG IS ABUSE-DETERRENT? HOW DO YOU MAKE A METHOD MORE ROBUST? HOW DO YOU ENSURE A LINKER WON’T BECOME TOXIC? HOW DO YOU GET A CLEARER SUPERNATANT? HOW DO YOU MONITOR ANALYTE CONCENTRATION OVER TIME? HOW DO YOU ADDRESS AN FDA RESPONSE LETTER ASAP? HOW DO YOU KEEP UP WITH CHANGING REGULATIONS? HOW DO YOU PREDICT EFFECTS OF POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU EVALUATE CONTAINER/CLOSURE SYSTEMS? HOW DO WE MAKE PACKAGING SAFER? HOW DO WE SPEED UP INNOVATION? HOW DO YOU GET A METHOD TO PERFORM AS EX-PECTED? HOW DO YOU KNOW HOW DRUG IS DISTRIBUTED IN A PATCH? HOW DO YOU MEASURE SURFACE ROUGHNESS? HOW DO YOU PREPARE A SCIENTIFICALLY SUPPORTED DEFENSE? HOW DO YOU TROUBLESHOOT A CHALLENGING METHOD? HOW DO YOU PERFORM A STUDY THAT HAS NEVER BEEN DONE? HOW DO YOU ADJUST A FORMULATION FOR TIMED RELEASE? HOW DO YOU MAKE A DRUG IS ABUSE-DETERRENT? HOW DO YOU MAKE A METHOD MORE ROBUST? HOW DO YOU ENSURE A LINKER WON’T BECOME TOXIC? HOW DO YOU GET A CLEARER SUPERNATANT? HOW DO YOU MONITOR ANALYTE CONCENTRATION OVER TIME? HOW DO YOU ADDRESS AN FDA RESPONSE LETTER ASAP? HOW DO YOU KEEP UP WITH CHANGING REGULATIONS? HOW DO YOU PREDICT EFFECTS OF POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU EVALUATE CONTAINER/CLO-SURE SYSTEMS? HOW DO WE MAKE PACKAGING SAFER? HOW DO WE SPEED UP INNOVATION? HOW DO YOU GET A METHOD TO PERFORM AS EXPECTED? HOW DO YOU KNOW HOW DRUG IS DISTRIBUTED IN A PATCH? HOW DO YOU MEASURE SURFACE ROUGHNESS? HOW DO YOU PREPARE A SCIENTIFICALLY SUPPORTED DEFENSE? HOW DO YOU TROU-BLESHOOT A CHALLENGING METHOD? HOW DO YOU PERFORM A STUDY THAT HAS NEVER BEEN DONE? HOW DO YOU ADJUST A FORMULATION FOR TIMED RELEASE? HOW DO YOU MAKE A DRUG IS ABUSE-DETERRENT? HOW DO YOU MAKE A METHOD MORE ROBUST? HOW DO YOU ENSURE A LINKER WON’T BECOME TOXIC? HOW DO YOU GET A CLEARER SUPERNATANT? HOW DO YOU MONITOR ANALYTE CONCENTRATION OVER TIME? HOW DO YOU ADDRESS AN FDA RESPONSE LETTER ASAP? HOW DO YOU KEEP UP WITH CHANG-

ING REGULATIONS? HOW DO YOU PREDICT EFFECTS OF POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU EVALUATE CONTAINER/CLOSURE SYSTEMS? HOW DO WE MAKE PACKAGING SAFER? HOW DO WE SPEED UP INNOVATION? HOW DO YOU GET A METHOD TO PERFORM AS EXPECTED? HOW DO YOU KNOW HOW DRUG IS DISTRIBUTED IN A PATCH? HOW DO YOU MEASURE SURFACE ROUGHNESS? HOW DO YOU PREPARE A SCIENTIFICALLY SUPPORTED DEFENSE? HOW DO YOU TROUBLESHOOT A CHALLENGING METHOD? HOW DO YOU PERFORM A STUDY THAT HAS NEVER BEEN DONE? HOW DO YOU ADJUST A FORMULATION FOR TIMED RELEASE? HOW DO YOU MAKE A DRUG IS ABUSE-DETERRENT? HOW DO YOU MAKE A METHOD MORE ROBUST? HOW DO YOU ENSURE A LINKER WON’T BECOME TOXIC? HOW DO YOU GET A CLEARER SUPERNATANT? HOW DO YOU MONITOR ANALYTE CONCENTRATION OVER TIME? HOW DO YOU ADDRESS AN FDA RESPONSE LETTER ASAP? HOW DO YOU KEEP UP WITH CHANGING REGULATIONS? HOW DO YOU PREDICT EFFECTS OF POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU EVALUATE CONTAINER/CLOSURE SYSTEMS? HOW DO WE MAKE PACKAGING SAFER? HOW DO WE SPEED UP INNOVATION? HOW DO YOU GET A METHOD TO PERFORM AS EXPECTED? HOW DO YOU KNOW HOW DRUG IS DISTRIBUTED IN A PATCH? HOW DO YOU MEASURE SURFACE ROUGHNESS? HOW DO YOU PREPARE A SCIENTIFICALLY SUPPORTED DEFENSE? HOW DO YOU TROUBLESHOOT A CHALLENGING METHOD? HOW DO YOU PERFORM A STUDY THAT HAS NEVER BEEN DONE? HOW DO YOU ADJUST A FORMULATION FOR TIMED RELEASE? HOW DO YOU MAKE A DRUG IS ABUSE-DETERRENT? HOW DO YOU MAKE A METHOD MORE ROBUST? HOW DO YOU ENSURE A LINKER WON’T BECOME TOXIC? HOW DO YOU GET A CLEARER SUPERNATANT? HOW DO YOU MONITOR ANALYTE CONCENTRATION OVER TIME? HOW DO YOU ADDRESS AN FDA RESPONSE LETTER ASAP? HOW DO YOU KEEP UP WITH CHANGING REGULATIONS? HOW DO YOU PREDICT EF-FECTS OF POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU EVALUATE CONTAINER/CLOSURE SYSTEMS? HOW DO WE MAKE PACKAGING SAFER? HOW DO WE SPEED UP IN-NOVATION? HOW DO YOU GET A METHOD TO PERFORM AS EXPECTED? HOW DO YOU KNOW HOW DRUG IS DISTRIBUTED IN A PATCH? HOW DO YOU MEASURE SURFACE ROUGH-

HOW DO YOU COMPLY WITH <USP 232/233>? HOW DO YOU KNOW WHEN TO CONDUCT E/L STUDIES? HOW DO YOU FULLY CHARACTERIZE AN ANTIBODY DRUG CONJUGATE? HOW DO YOU MONITOR CHARGE VARIANTS AND DEGRADATIONS? HOW DO YOU DETECT POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU RE-OPTIMIZE AN ELISA METHOD WHEN A REAGENT LOT CHANGES? HOW DO YOU IDENTIFY UNKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YOU KNOW IF A BIOSIMI-LAR IS SIMILAR ENOUGH? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU EVALUATE PRODUCT PACKAGING? HOW DO YOU IDENTIFY THE SOURCE OF CONTAMINA-TION? HOW DO YOU KNOW WHAT ANALYTICAL TECHNIQUE TO USE? HOW DO YOU SIMULTANEOUSLY TEST FOR TWO BYPRODUCTS? HOW DO YOU CHARACTERIZE AN UNKNOWN? HOW DO YOU EVALUATE STABILITY IN HOT, HUMID ENVIRONMENTS? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU KNOW IF A BIOSIMILAR IS SIMILAR ENOUGH? HOW DO YOU IDENTIFY UNKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YOU RE-OPTIMIZE AN ELISA METHOD WHEN A REA-GENT LOT CHANGES? HOW DO YOU DETECT POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU MONITOR CHARGE VARIANTS AND DEGRADATIONS? HOW DO YOU COMPLY WITH <USP 232/233>? HOW DO YOU KNOW WHEN TO CONDUCT E/L STUDIES? HOW DO YOU FULLY CHARACTERIZE AN ANTIBODY DRUG CONJUGATE? HOW DO YOU MONITOR CHARGE VARIANTS AND DEGRADATIONS? HOW DO YOU DETECT POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU RE-OPTIMIZE AN ELISA METHOD WHEN A REAGENT LOT CHANGES? HOW DO YOU IDENTIFY UNKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YOU KNOW IF A BIOSIMILAR IS SIMILAR ENOUGH? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU EVALUATE PRODUCT PACKAGING? HOW DO YOU IDENTIFY THE SOURCE OF CONTAMINATION? HOW DO YOU KNOW WHAT ANALYTICAL TECHNIQUE TO USE? HOW DO YOU SIMULTANEOUSLY TEST FOR TWO BYPRODUCTS? HOW DO YOU CHARACTERIZE AN UNKNOWN? HOW DO YOU EVALUATE STABILITY IN HOT, HUMID ENVIRONMENTS? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU KNOW IF A BIOSIMILAR IS SIMILAR ENOUGH? HOW DO YOU IDENTIFY UNKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YOU RE-OPTIMIZE AN ELISA METHOD WHEN A REAGENT LOT CHANG-ES? HOW DO YOU DETECT POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU MONITOR CHARGE VARIANTS AND DEGRADATIONS? HOW DO YOU COMPLY WITH <USP 232/233>? HOW DO YOU KNOW WHEN TO CONDUCT E/L STUDIES? HOW DO YOU FULLY CHARACTERIZE AN ANTIBODY DRUG CONJUGATE? HOW DO YOU MONITOR CHARGE VARI-ANTS AND DEGRADATIONS? HOW DO YOU DETECT POST-TRANSLATIONAL MODIFICATIONS? HOW DO YOU RE-OPTIMIZE AN ELISA METHOD WHEN A REAGENT LOT CHANGES? HOW DO YOU IDENTIFY UNKNOWN METABOLITES? HOW DO YOU OPTIMIZE AN ANALYTICAL METHOD UNDER GMP? HOW DO YOU KNOW IF A BIOSIMILAR IS SIMILAR ENOUGH? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU EVALUATE PRODUCT PACKAGING? HOW DO YOU IDENTIFY THE SOURCE OF CONTAMINATION? HOW DO YOU KNOW WHAT ANALYTICAL TECHNIQUE TO USE? HOW DO YOU SIMULTANEOUSLY TEST FOR TWO BYPRODUCTS? HOW DO YOU CHARACTERIZE AN UNKNOWN? HOW DO YOU EVALUATE STABILI-TY IN HOT, HUMID ENVIRONMENTS? HOW DO YOU KNOW RAW MATERIALS ARE PURE? HOW DO YOU KNOW IF A BIOSIMILAR IS SIMILAR ENOUGH? HOW DO YOU IDENTIFY UN-

How do you know a cGMP method validation is “phase appropriate”? How do you decide when to conduct E/L studies? How do you quickly identify the source of contamination? For companies looking for a true development CRO, EAG offers deep experience in analytical method development, program design and complex study execution—with the technical and regulatory know-how to help overcome R&D roadblocks, avoid regulatory setbacks and uncover sources of problematic manufacturing issues.

DRUG DEVELOPMENT | PHARMACEUTICALS

www.eag.com/pharmaceutical

HOW DO YOU MAKE BETTER DEVELOPMENT DECISIONS FASTER?

COMPREHENSIVE CMC ANALYTICAL SUPPORT• Analytical method development and

validation • Stability (developmental and

commercial ) - All common ICH and custom

conditions in 38,000 ft3 of cGMP storage, including photostability

- Fully-compliant LIMS inventory and environmental monitoring systems

• Elemental impurities by ICP-MS for ICH Q3D and USP <232>/<233>

• QC release testing • Reference standard qualification and

program management• Vendor qualification

EXTRACTABLES & LEACHABLES• Controlled extraction studies• Leachables method development and

validation• Leachables stability programs• Toxicity evaluation for leachables• E/L consulting and program design

COMPOSITION & SURFACE ANALYSIS • Layer structure and chemical

composition• Particle size and composition• Chemical imaging of drug and drug

product• Quantitation and distribution of active

ingredients, excipients and coatings at the sub-micron scale

INSTRUMENTATION & TECHNIQUES

CHROMATOGRAPHY/SEPARATIONS• HPLC, UPLC• Semi-prep HPLC• GC-MS• LC-MS• GPC• GC• SEC & IC

DISSOLUTION• Type I, II, III• IR, ER, MR• Bath & bathless• Inline UV

DETECTION• HPLC (UV, PDA, FL, RI, ELSD)• High-Resolution MS• MS• MS/MS • MS-IT• MS-TOF• CAD• Conductivity

ELEMENTAL/PURITY ANALYSIS• ICP-MS• ICP-OES• GDMS• XRF• IC• AA• Microwave digestion

STABILITY• cGMP-compliant• All ICH conditions • Custom conditions• Photostability• Fully validated Rees monitoring

system• Redundant chamber systems• 100% backup power supply• 38,000 cubic feet stability storage

COMPOSITION/IDENTITY• FTIR• Raman• XPS/ESCA• TOF-SIMS• XRD• Thermal Analysis (TGA/DSC/DTA)• NMR• Auger

MICROSCOPY/IMAGING• SEM• Optical Profilometry• Optical Microscopy• AFM• TEM

EAG Laboratories uses state-of-the-art instrumentation in the areas of spectroscopy, chromatography and microscopy. We offer a secure, DEA-licensed stability suite that covers all ICH conditions.

INVESTIGATIVE PROBLEM SOLVING, CONSULTING & LITIGATION SUPPORT • Contaminant investigations• Isolation, elucidation, identification

and characterization of known and unknown materials

• Failure analysis of product, packaging and manufacturing processes

• Evaluation of supply chain inputs• Litigation support, including expert

testimony for intellectual property and product liability challenges

RADIOLABELING & CUSTOM SYNTHESIS • cGMP, GLP-certified and R&D

materials• Stable-label active ingredients and

metabolites: 2H and 13C• Radiolabeled active ingredient and

metabolites: 3H, 14C and other labels• Custom small-scale synthesis of

compounds and reference standards• Dedicated analytical support for

qualification and generation of certificates of analysis

ENVIRONMENTAL RISK ASSESSMENT FOR PHARMACEUTICALS • Product chemistry• Aquatic and terrestrial toxicology• Metabolism• Environmental fate

ABC Laboratories is now part of EAG

PHARMACEUTICAL DEVELOPMENT: HOW WE CAN HELP

Copyright © 2017 EAG, Inc. M-012516 3.21.2017

EAG Laboratories is a global scientific services company serving clients across a vast array of technology-related industries. Through multi-disciplinary expertise in the materials, engineering and life sciences, EAG helps companies innovate and improve products, ensure quality and safety, strengthen supply chains, protect intellectual property and comply with evolving global regulations.

+1 800.538.5227 • EAG.COM