Pharmaceutical Services


hover text

TERA is a world leader in deriving safe dose estimates for human health.


At TERA, pharmaceutical services build on our strength as a leader in toxicological risk assessment. Whether you need an Occupational Exposure Limit set for an active pharmaceutical ingredient, are concerned about the safety implications of an impurity in your raw material or finished product, or are not sure how a regulatory guidance applies to your particular situation, we have the expertise to meet your needs. Our highly qualified team includes occupational physicians, industrial hygienists, pharmacists, and board-certified toxicologists.


What's the next step?


To get more information about TERA’s pharmaceutical services or to talk to someone about how TERA can help you, please call us at: 513-542-7475.


Or send an email to:


Occupational Exposure Limits (OEL) and Workplace Risk Assessment

OccupationalWe specialize in producing OELs for small and large molecules, complex biologic materials, antibodies, and other proteins. Our assessments feature state-of-the-art weight of evidence analysis for point of departure and uncertainty factor determinations. We provide sound, science-based limits that protect worker health.




ExpandLearn more


Occupational Exposure Limits (OEL) Development


TERA can help pharmaceutical companies develop defensible science-based OELs and hazard bands.  We routinely develop safe limits for pipeline and legacy active pharmaceutical ingredients (APIs). 


Hazard Banding (Control Banding)


Hazard banding provides a tool for hygienists to perform risk management in the workplace when the available data are limited.  TERA can help you effectively manage risk by applying hazard banding to new and data-poor compounds.



Health and Safety Clearance of Chemicals


TERA can develop customized frameworks for conducting screening level risk assessments for chemicals newly introduced to facility operations.







Product Quality Limits for Small and Large Molecules and Medical Devices

pharmaceuticalGet to know your impurities better.  Trace amounts of impurities are present in virtually all drug products.  Some of them are harmless, while others can present a risk to human health.  TERA sets safe levels for impurities to protect human health.  We can develop processes and train your staff in human health risk assessment to help ensure product safety.


Expand Learn More


Impurity Acceptable Daily Exposure (ADE) Values


The ADE concept is based on "the daily exposure to a chemical, over a predefined period which appears to be without appreciable risk on the basis of all known facts at the time."
TERA provides health-based ADE limits for pharmaceutical impurities including starting materials, intermediates, reaction by-products, heavy metals, process reagents, leachables, degradants, and interaction products.  Using the most sensitive endpoint, TERA will integrate available pharmacokinetic, pharmacodynamic, and state-of-the-art dose-response modeling approaches to provide safe daily human exposure limits. 

TERA can also design, monitor, and manage toxicological testing of impurities in pharmaceutical products.


Excipient Safety Evaluation


From simple to novel, TERA can provide safe exposure limits for excipients taking into consideration the effects of excipients on the bioavailability of the active pharmaceutical ingredient (API).



Cleaning Validation Limits


The objectives of Good Manufacturing Practice (GMP) include prevention of possible contamination of a manufactured product with substances carried over from previous products.  Substances of concern include carryover of the API, excipients, residues of cleaning agents, and lubricants.  TERA can help you:


    + Determine whether dedicated production lines are recommended for your products;


    + Set maximum allowable carryover limits for products manufactured in shared facilities.




Risk Assessment Process Development and Training

TrainingTERA recognizes that different occupational professionals within a company can have very different approaches to risk assessment.  Often, this is attributable to differences in the process used for deriving safe limits.  TERA specializes in harmonizing risk assessment processes and can help you develop internal processes that are in line with company and regulatory policies.



Expand Lean More


Procedural Assistance


TERA can help you develop Standard Operating Procedures (SOPs), work instructions, and/or guidance documents using the best available science to support procedural steps in risk assessment.


Health and Safety Clearance of Chemicals


TERA can develop and implement customized frameworks for conducting screening level risk assessments for chemicals in facility operations.


Pharmaceutical Risk Assessment Training Courses


TERA provides hands-on training in hazard characterization, dose-response modeling, and limit setting for both cancer and non-cancer effects.  TERA can tailor training courses to the needs of pharmaceutical risk assessors, managers and other profeesionals involved in setting safe exposure limits.


TERA provides several risk resources and training programs through our Global Outreach Program.  These programs include our popular "Dose-Response Assessment Boot Camp" which provides intensive, hands-on training in hazard characterization and dose-response assessment for human health risk assessments.  Learn more.


Safety Data Sheet Development

Using a state-of-the-art weight of evidence analysis, we can author, audit, and update GHS-Compliant Safety Data Sheets (SDS) for APIs and other chemicals.  We will ensure that your documents provide the information needed to protect your workers, the environment, and achieve regulatory compliance.


Chemical Risk Assessment Method Development

There are many gaps and deficiencies in the risk assessment process. TERA can help you develop, review, and communicate limits and the analyses behind them.  TERA also provides training programs to facilitate understanding of risk assessment methodologies by risk assessors, managers, and the general public.


Expand Learn More


Mode of Action (MOA) Analysis and Dose-Response Frameworks


Evaluation of mode of action (MOA) plays a critical role in both the hazard characterization and dose-response portions of assessments.  TERA can design and conduct studies targeted to address key MOA questions.  We have active research projects aimed at developing approaches to quantitatively describe the dose-response relationship for chemicals with multiple MOAs.  One area of emphasis has centered on the use of early effects and systems biology to support dose-response assessment.    Learn more.


Quantitative Risk Assessment


Quantitative risk assessment provides data based risk estimates derived by mathematically modeling and statistically analyzing the experimental toxicity data. TERA scientists have extensive experience with the tools of quantitative risk analysis, and continue to research and develop new analytical methods to improve risk assessment.    Learn More.


Toxicological Reviews

TERA’s staff has a detailed understanding of the latest developments in risk science and toxicology and how it is applied practically in risk assessment.  Our staff have developed or reviewed the documentation for hundreds of non-cancer and cancer risk assessment values and use the knowledge and experience gained to move the science of risk assessment forward.  Learn More


Support for Nonclinical Drug Discovery and Development

TrainingOur team of toxicologists has extensive experience in drug discovery and development, and a proven track-record of managing nonclinical testing programs that have contributed to marketing authorization approvals. Our experience includes evaluations of small molecules, traditional herbal medicines, biologics, and medical devices in numerous therapeutic areas.



Expand Learn More


Risk Assessment Training


Hands-on training in hazard characterization, dose-response modeling and limit setting for both cancer and non-cancer effects, tailored to the needs of pharmaceutical risk assessors.


Regulatory Writing


TERA can provide expertly prepared nonclinical summaries and overviews for regulatory submissions, investigator brochures, and annual regulatory updates.  TERA can also help you respond to regulatory comments and resolve science-based regulatory issues.


Design, Interpretation and Reporting of Pharmacology, Toxicology, and Safety Pharmacology Studies

TERA can aid in designing scientifically sound nonclinical studies. We can also assist in monitoring studies placed at CROs, reviewing study reports, and providing feedback.


Expert Reviews


TERA is a world leader in peer review.  Our expert reviews of nonclinical data packages enable you to make important regulatory and process decisions, as well as facilitating an understanding of key study strengths and weaknesses and their appropriateness for your particular use. We can also identify data gaps, inconsistencies, and the next steps for future work. Learn more.


Alliances and Partnerships

AlliancesIn solving risk problems for a diverse array of government and private sponsors, we apply a collaborative philosophy that emphasizes partnership building, allowing us to expand our pool of expertise, build on multiple perspectives, and ensure the use of the best science. These strengths form the basis for our development of independent and science-driven analyses for a range of risk assessment needs.


Expand Learn More


Strategic Regulatory Consulting (SRC)

TERA’s pharmaceutical toxicology group provides comprehensive occupational health, pharmaceutical, and medical device support from start to finish. 


Learn more.



Alliance for Risk Assessment (ARA)


TERA is a proud member of the Alliance for Risk Assessment, a collaborative effort of organizations dedicated to supporting public health protection by improving the process and efficiency of risk assessment. Given a limited supply of time, resources, and know-how, public health protection is an effort that requires cooperation, organization, and prioritization. The Alliance aims to help.  Learn more.


TERA Fellows Program


The TERA Fellow Programs is a collaboration with senior scientists who provide additional depth in specialized areas of toxicology.  TERA Fellows share TERA's mission and values, and seek to improve risk assessment practice.  Learn more.


Occupational Alliance for Risk Science (OARS)


The Occupational Alliance for Risk Science (OARS) is an initiative to facilitate sharing of information with workers and occupational health and safety professionals. OARS provides a forum for information exchange about exposure guidance for chemical stressors, methods for improving occupational risk assessments, and training opportunities.  Learn More.


Pharmaceutical Resources and Tools
TERA develops tools to improve and harmonize the risk assessment process. 


Expand Learn More


Some resources and tools are under underdevelopment.


Pharmaceuticals in the Environment (PiE) Support


Pharmaceuticals in the EnvironmentTERA can evaluate the relative toxicological risk of pharmaceuticals in the environment, including regulatory clean-up and compliance, product stewardship, aquatic and environmental fate, transformation, and exposure.  TERA has a large network of ecological toxicologists with a range of expertise that can help solve all PiE related problems.



  • Rat and Mouse Default Values for Body Weight, Food and Water Consumption
    Inhalation Related Dosimetric Adjustment
  • Benchmark Dose Modeling
  • Pharmacokinetic Calculator - coming soon
  • Safe Dose Calculators - coming soon
  • Search Strategy SOP - coming soon

    Pharma Guidance Documents


    General Impurities


    Genotoxic Impurities


    bullet ICH, ICH Guideline M7 on assessment and control of DNA reactive (mutagenic)   impurities in pharmaceuticals to limit potential carcinogenic risk. IVH Guideline,2013, 1, 27.

    bullet EMA. Guideline on the Limits of Genotoxic impurities. Committee for Medicinal Products for Human Use (CHMP) 2006, 3-8.


    bullet EMA, Questions and answers on the Guideline on the limits of genotoxic impurities;EMA/CHMP/SWP/431994/2007. Committee for Medicinal Products for Human Use CHMP) 2010, 1-6.


    bullet Muller, L , Mauthe RJ, Riley CM, Andino MM, Antonis DD, Beels C, DeGeorge J, De Knaep AG, Ellison D, Fagerland JA, Frank R, Fritschel B, Galloway S, Harpur E, Humfrey CD, Jacks AS, Jagota N, Mackinnon J, Mohan G, Ness DK, O'Donovan MR, Smith MD, Vudathala G, Yotti L.. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regulatory Toxicology and Pharmacology 2006, 44, 198-211.


    Specific Types of Impurities


    Shared Facilities



    Occupational Exposure/Clean Limits.



    Additional Pharmaceutical Risk Assessment Resources


    bullet Ader AW, Sussman RG, Kimmel TA, Ku RH. 2010. Procedures for Determining an Acceptable Daily Exposure (ADE) under Risk-MaPP: Approaches for Developing and Documenting Acceptable Limits for Product Cross-Contamination Purposes. White paper. SafeBridge Consultants, Inc. Mountain View, California and New York, New York. pp. 1-4.


    bullet Bercu JP, Sharnez R, Dolan DG. 2013. Advancing toxicology in RiskMAPP: Setting ADEs based on the subsequent drug substance. Regul Toxicol Pharmacol. 65(1):157-61.


    bullet Bercu JP, Dolan DG. 2013. Application of the threshold of toxicological concern concept when applies to pharmaceutical manufacturing operations intended for short term clinical trials. Regul Toxicol Pharmacol. 65(1):162-7


    bullet Calaude JR. 2007. General Principles for the Safety Assessment of Excipients.


    bullet Dolan DG, Naumann BD, Sargent EV, Maier A, Dourson M. 2005. Application of the threshold of toxicological concern concept to pharmaceutical manufacturing operations. Regul Toxicol Pharmacol. 43(1):1-9.


    bullet Dourson ML, Parker AL. 2007. Past and Future Uses of Default Assumptions and Uncertainty Factors: Default Assumptions, Misunderstandings, and New Concepts. Hum Ecol Risk Assess. 13: 82–87


    bullet ECETOC (European Center for Ecotoxicology and Toxicology of Chemicals). 2010.Workshop on Guidance on Assessment Factors to Derive a DNEL. Brussels, Belgium


    bullet EMA (European Medicines Agency). 2008. Guideline on the Specification Limits For Residues Of Metal Catalysts or Metal Reagents. Canary Wharf, London


    bullet EMA (European Medicines Agency). 2007. Guideline on Excipients In The Dossier For Application For Marketing Authorization Of A Medicinal Product. Canary Wharf, London


    bullet EMA (European Medicines Agency). 2006. Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. Canary Wharf, London


    bullet EMA (European Medicines Agency). 2006. Guideline on the Limits of Genotoxic Impurities. Canary Wharf, London


    bullet FASS. 2007. Environmental classification of pharmaceuticals in – guidance for pharmaceutical companies.


    bullet FDA (Food Drug Administration). 2004. Guidance for Industry PAT- A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Department of Health and Human Services, Food and Drug

    Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) Pharmaceutical CGMPs.


    bullet FDA (Food Drug Administration). 2005.  Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Center for Drug Evaluation and Research (CDER). Pharmacology and Toxicology.


    bullet FDA (Food Drug Administration). 2011 Guidance for Industry Process Validation: General Principles and Practices. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) , Center for Biologics Evaluation and Research (CBER) , Center for Veterinary Medicine (CVM). Pharmacology and Toxicology.


    bullet FDA (Food Dung Administration). 2005. Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Pharmacology and Toxicology.


    bullet FDA (Food Drug Administration). 2008. Guidance for Industry  Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches. U.S. Department of Health and Human Services  Food and Drug Administration Center for Drug Evaluation and Research (CDER). Pharmacology and Toxicology.


    bullet Flatman S. 2013. Impurities in Biotechnology Products –Experience of Setting Specifications. Jury Great Russell Street, London.


    bullet Gaylor DW, Kodell RL. 1980.  Linear Interpolation Algorithm For Low Dose Risk Assessment Of Toxic Substances. J Environ Pathol. Toxicol Volume 4, Number 5, 6.


    bullet Hebestreit P. 2009. Addressing specific regulatory excipient requirements in the marketing authorization. Global Regulatory Affairs Pharma Ingredients & Services BASF SE PharmSciFair Nice


    bullet ICH (International Conference of Harmonization). 2006. Impurities In New Drug Substances Q3A(R2).


    bullet ICH (International Conference of Harmonization). 2006. Impurities In New Drug Products Q3B(R2).


    bullet ICH (International Conference of Harmonization). 2011. Impurities: Guideline For Residual Solvents Q3C(R5).


    bullet IPEC (International Pharmaceutical Excipients Council). 2008. Qualification of Excipients for Use in Pharmaceuticals. IPEC-Americas: Arlington, VA.


    bullet Matthews EJ, Kruhlak NL, Benz RD, Contrera JF. 2004. Assessment of the Health Effects of Chemicals in Humans: I. QSAR Estimation of the Maximum Recommended Therapeutic Dose (MRTD) and No Effect Level (NOEL) of Organic Chemicals Based on Clinical Trial Data. Curr Drug Discov Technol. 1:61-76.


    bullet Mouton J, Vinks AA, Punt NC. 1997. Pharmacokinetic-pharmacodynamic modeling of activity of Ceftazidime during continuous and Intermittent Infusion. Antimicrob Agents Chemother. 41(4): 733–738.


    bullet Naumann BD, Silverman KC, Dixit R, Faria EC, Sargent EV. 2001. Case Studies of Categorical Data-Derived Adjustment Factors. Hum Ecol Risk Assess. 7(1):61-105.


    bullet Renwick AG, Lazarus NR. 1998. Human Variability and Noncancer Risk Assessment- An Analysis of the Default Uncertainty Factor. Regul Toxicol Pharmacol. 27(1 Pt 2):3-20.


    bullet Sharnez R, Horner MJ, Spencer A, Tholudur A. 2013.  Biopharmaceutical Cleaning Validation: Leveraging Acceptable Exposure of Host cell Protein to Set Acceptance Limits for Inactivated Product. JVT. Institute of Validation Technology.


    bullet Sharnez R, To A. 2011. Multiproduct Cleaning Validation: Acceptance Limits for the Carryover of Inactivated API Part I- The Comparable Quality Approach. JVT. Institute of Validation Technology.


    bullet Sharnez R, Spencer A, Romero J, Runkle S, Carolan C, Hayes R, Mott A, Clark ME, Wyman E, Rasmi M, Donat S, Bellorado K. 2012. Methodology for Assessing Product Inactivation during Cleaning Part I: Experimental Approach and Analytical Methods. JVT. Institute of Validation Technology.


    bullet Silverman KC, Naumann BD, Holder DJ, Dixit R, Faria EC, Sargent EV, Gallo MA. 1999. Establishing Data-Derived Adjustment Factors from Published Pharmaceutical Clinical Trial Data. Hum Ecol Risk Assess. pp. 1059-1089.


    bullet Solecki R, Davies L, Dellarco V, Dewhurst I, Raaij Mv, Tritscher A. 2005. Guidance on setting of acute reference dose (ARfD) for pesticides. Food Chem Toxicol. 43(11):1569-93.


    bullet Tourneau CL, Lee JJ, Siu LL. 2009. Dose Escalation Methods in Phase I Cancer Clinical Trials. J Natl Cancer Inst. 101:708-720.


    bullet Walsh A. 2011. Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I 47-83, II 44-49. Pharmaceutical Engineering.


    bullet Walsh A. 2011.  Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide. Pharmaceutical Engineering, vol 31. No.6. pp. 1-7.62.


    bullet WHO (World Health Organization). 1994. Environmental Health Criteria 170 Assessing Human Health Risks Of Chemicals: Derivation Of Guidance Values For Health-Based Exposure Limits. World Health Organization, Geneva.