Resolian is a bioanalysis and drug metabolism laboratory headquartered in Malvern, Pennsylvania.[S1][S3] Readers who know it as Alliance Pharma are in the right place: that was the name of the Malvern business until the group adopted the Resolian brand in 2023, after combining with Drug Development Solutions in the United Kingdom and Denali Medpharma in China.[S1][S13] The group now describes five laboratories on four continents.[S2] What it sells is measurement. Concentrations of a drug and its metabolites in biological matrices, the enzyme and transporter work that predicts how a compound is handled, biomarker assays, immunogenicity testing, and the chemistry that supports a manufacturing filing.[S4][S5][S6][S8] No full toxicology service line was identified on the pages reviewed; that is an absence in those pages, not a finding that Resolian does not offer toxicology, and understanding that boundary is the first thing a sponsor needs from this profile.
Services relevant to US drug developers
What is and is not in scope
No toxicology, safety pharmacology, pathology, infectious disease or medical device testing service line was found on the company website.[S4][S8] The published divisions are bioanalytics, analytical sciences and supporting sciences.[S2] Sponsors should confirm whether Resolian will arrange any in-life work, which site will house animals, and how samples will be transferred, or the two are contracted separately from the start. One qualification is needed. A promotional tile on the bioanalytics page refers to a tile mentioning in vivo testing services, whose linked page was unavailable when reviewed, but the page it links to was not available, so nothing beyond that single line could be confirmed.[S4] A sponsor who needs in-life work should treat that as a question for the company rather than as a described capability.
Regulated and exploratory bioanalysis
The bioanalytical division covers small molecules, peptides, biologics, antibody-drug conjugates and oligonucleotides, using liquid chromatography with tandem mass spectrometry, ligand binding assays, flow cytometry, high resolution mass spectrometry and polymerase chain reaction methods.[S4] Named areas include large molecule mass spectrometry, immunoassay, peptide analysis, conjugate modalities including antibody-drug and peptide-drug conjugates, and clinical drug-drug interaction studies.[S4] Both regulated and non-regulated work is offered, sponsors should specify the applicable quality system, the validation status and the documentation required for each assay, and the two should be scoped differently.
Drug metabolism and pharmacokinetics
In vitro work covers aqueous solubility, metabolic stability in microsomes, S9 fractions, hepatocytes and recombinant enzymes, plasma protein binding by several methods, reaction phenotyping across cytochrome P450, UGT and carboxylesterase enzymes, permeability in Caco-2 and MDCK systems, cytochrome P450 induction and both direct and time-dependent inhibition, and transporter substrate and inhibition assays across the major efflux and uptake transporters.[S5] In vivo pharmacokinetic and toxicokinetic work in rodents is offered alongside it, positioned as support for discovery and for studies enabling an investigational new drug application.[S5] Metabolite identification is listed as a separate capability.[S5]
Biomarkers, cell and gene therapy, and CMC analysis
Biomarker work spans protein platforms including electrochemiluminescence and single-molecule immunoassay systems, chromatographic and high resolution mass spectrometry methods, and quantitative and droplet digital polymerase chain reaction for nucleic acid markers.[S6] For cell and gene therapy programmes the company lists support across chimeric antigen receptor T cells, adeno-associated virus and lentiviral vectors, gene editing constructs, lipid nanoparticle formulations, messenger RNA and small interfering RNA, using flow cytometry, mass spectrometry, immunoassay, enzyme-linked immunospot and polymerase chain reaction methods.[S7] Separately, the analytical sciences division in the United Kingdom performs manufacturing-facing chemistry, including nitrosamine testing, impurity and elemental impurity analysis, materials characterization, and extractables and leachables work.[S8][S11] A sponsor placing chemistry work should note that this division sits in the United Kingdom rather than at the United States site.[S2][S11]
Quality, compliance, and inspections (as stated by the company)
The company states that it has operated to good practice standards since 1998, covering good laboratory practice, good clinical practice, current good manufacturing practice and computer system validation, with more than thirty quality staff.[S9] The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.[S9] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.[R2] Site-specific statements are more concrete than the group-level ones: the Australian laboratory cites accreditation by the national testing authority there, and both the United Kingdom and Australian sites name software compliant with the electronic records regulation.[S10][S11] The company also states that it has completed regulatory inspections by the Food and Drug Administration, the Environmental Protection Agency, the European Medicines Agency, the United Kingdom medicines regulator and the Australian authority.[S9] Completing an inspection is not an approval or certification of the laboratory.[R6]
No AAALAC, USDA, OLAW or IACUC statement was found for the US operation on the pages reviewed; that is an absence in those pages, not a finding about the status of the company.[S9] The only animal-related statement located is a United Kingdom licensing list that includes an animal vivarium licence, which is a different national framework.[S9] Since the site describes rodent pharmacokinetic work, a sponsor whose study involves live animals should ask where those animals are housed and under whose oversight, and confirm the answer in the protocol.
The Malvern business operated as Alliance Pharma; the Resolian brand was adopted in 2023[S1][S13]
Headquarters
17 Lee Boulevard, Malvern, PA 19355, United States[S3]
Sites
Five laboratories: Malvern, Pennsylvania; Fordham and Sandwich, United Kingdom; Brisbane, Australia; Chongqing, China[S2]
Origins
United Kingdom laboratory dating to 1997; Malvern founded as Alliance Pharma in 2007; Drug Development Solutions acquired 2022; Denali Medpharma acquired 2023[S13]
Ownership
Not stated on the site; no parent company or investor is named
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise
In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies Replicate unknown pathological models and Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc. (Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
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