Pharmaceutical Services – TERA

Pharmaceutical Services

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

Product Quality Limits for Small and Large Molecules and Medical Devices

Product Quality Limits for Small and Large Molecules and Medical Devices

Get 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.

Alliances and Partnerships

Alliances and Partnerships

In 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.

Support for Nonclinical Drug Discovery and Development

Support for Nonclinical Drug Discovery and Development

Our 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.

Pharmaceutical Resources

Pharmaceutical Resources

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

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The WEEL Process

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The development of new or revision of existing WEELs is typically assigned to voluntarily designated subcommittees. A subcommittee usually comprises 3 – 4 members from the WEEL Committee. New WEELs are developed using the OARS-WEEL administrative standard operating procedure (SOP), while existing WEELs are usually revised every 10 years, unless the availability of significant new data which may impact the existing WEEL value compels the committee to make a revision sooner. The OARS-WEEL SOP contains procedures and guidelines governing conflicts of interest, draft document preparation, literature searches, draft document review, balloting process, post-ballot WEEL documentation quality assurance scientific review, and publication.

Once a subcommittee has prepared a draft WEEL document, a review of the draft is scheduled for the next available Committee meeting. The WEEL Committee members are expected to have reviewed all such drafts prior to the meeting. If no major changes are necessary to a draft, the attending Committee membership may, by a simple majority, approve the WEEL for balloting. Alternatively, the Committee may direct the subcommittee to revise the WEEL and present it for further discussion at a future meeting. If a ballot is not approved by a two-thirds majority of non-abstaining Committee members, it is discussed at the next Committee meeting to determine the appropriate course of action. Once the WEEL is approved by a two-thirds majority of non-abstaining Committee members, copies of ballot comments are forwarded to the designated subcommittee and all substantive comments must be addressed in the final draft. If resolution of a substantive comment results in a change to the WEEL value or a change in the basis for the value, the draft must be re-balloted.

Once all comments have been addressed on a successfully balloted draft, document formatting and editorial review are performed by TERA, before the draft WEEL document is made available for public comment (usually for a period of 30 days but may be extended if the need arises). After the public comment period has elapsed, comments are addressed by the subcommittee responsible for that specific draft, after which the WEEL documentation is submitted to Toxicology and Industrial Health (TIH), a peer-reviewed medical journal that covers research in the fields of occupational health and toxicology, for publication. A thorough review of the galley proof by the scientific content quality coordinator at TERA, and proofreaders and editors at TIH is the penultimate step before eventual publication of the WEEL documentation.