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Pace Analytical Life Sciences
Pace Analytical Life Sciences is listed as a large business research supplier in the Scientist.com network, with 15 sites in 2 countries and 2 service areas.
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Sites
15
Countries
2
Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Large business
Animal Science and Welfare Audits
- Vendor Audits/Qualifications vendor audits for non-GLP and GLP nonclinical CROs throughout the US and Canada.
Biomarkers
- Antimicrobial Effectiveness Testing Measure the efficacy of anti-microbial preservatives added to a product.
Chemical and Compound Analysis
- API Physical Characteristics Characterize physical and chemical properties of new drug molecules to develop safe, effective, and stable dosage forms.
- Chemical Stability Measure the stability of small molecules in solution.
- Chiral Separation Purify therapeutically active isomers of drug candidates.
- Differential Scanning Calorimetry Elucidate the thermodynamics associated with conformational transitions.
- Dissolution Profiling Measure release of API from formulation (tablet or capsules) under GMP guidelines.
- Elemental Impurity Analysis Identify and evaluate the presence of heavy metals in pharmaceuticals.
Show all 12 in Chemical and Compound Analysis
- Excipient Compatibility Test excipients for drug formulation, effects of temperature, time, humidity, pH and light exposure as well as excipient release.
- Isothermal Titration Calorimetry An ITC assay will be established and optimised for the affinity measurement of test substance to target molecule.
- MALDI-TOF Analysis Use mass spectrometry technique to analyze compound, biomolecules and large organic molecules.
- Photostability Measure drug degradation rates after exposure to various light sources.
- Solubility Studies Analyze substances for kinetics of solubility using nephelometry and UV-Vis spectrometry.
- Spray Drying Convert a liquid into a powder by rapidly drying the mixture and removing the moisture component.
Chemistry, Manufacturing and Controls (CMC)
- Analytical Development and Validation Request services related to Analytical Development and Validation
- API and Drug Product Stability Testing API and Drug Product Stability Testing.
- API Stress Testing Studies Develop analytical methods to predict stability problems and identify degradation products/pathways under forced degradation conditions.
- API/ Excipients Compatibility Studies Delineate real and possible interactions between potential formulation excipients and the API as an important risk reduction exercise early in formulation development.
- API/DP specific test methods API/DP specific test methods (e.g., stability indicating HPLC assay and purity)
- Chemistry Manufacturing Controls Access contract manufacturing and regulatory guidance in setting specifications and drug dosage formulations.
Show all 23 in Chemistry, Manufacturing and Controls (CMC)
- Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
- Compendial test methods Run Compendial test methods (e.g., KF)
- Crystallization studies Crystallization studies
- Drug Formulation Combine substances including the active drug into a final product with the desired metabolic and therapeutic properties.
- Drug product packaging and labeling Drug product packaging and labelling
- Drug Product Stability Use accelerated stress conditions to determine degradation pathways and identify manufacturing issues.
- Drug Substance and Drug Product Characterization and Manufacturing Drug Substance and Drug Product Characterization and Manufacturing.
- Fill and Finish Processing Confirm final product sterility, formulation and packaging in the biopharmaceutical process.
- Forced Degradation Run light, heat, humidity, acid hydrolysis and oxidation tests to evaluate substance degradation.
- ICH-compliant stability testing Perform ICH-compliant stability testing
- ISO Testing Services for Quality Assessments Testing Services follow standards developed by the International Organization for Standardization (ISO), ensuring consistency, accuracy, and international comparability in various industries including manufacturing...
- Milling, grinding, spray-drying Milling, grinding, spray-drying
- Polymorph Screening Screen for unwanted API forms resulting from the drug formulation process.
- Salt Form Selection Use high-throughput automated arrays to combine APIs with multiple salts and ions to optimize formulation.
- Tablet Manufacturing Use automatic or semi-automatic machinery to create various standard and non-standard tablets.
- Thermal Analysis Characterize compounds based on calorimetry and thermodynamic data.
- Thermo Scientific iCAP Q ICP-MS Expand your analytical capabilities with this complete trace elemental analysis solution for your high-throughput lab.
Show all 81 services
Clinical Consulting
- IND Writing Consulting Consulting for an Investigational New Drug Application
- Regulatory Compliance & Documentation Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
Discovery Chemistry
- Extractable and Leachable Assessment Quantify potential impurities from container closures & packaging.
- Leachable and extractable testing Leachable and extractable testing
DNA & RNA
- Gene/Oligo Synthesis Synthesize oligonucleotide or gene for microarrays, RT-PCR and PCR cloning.
Drug Development
- Consulting Services Work with consultants who provide expert advice in various areas of research and technology.
- Large Molecule Drug Development Consulting Develop large molecule drugs and complex biologics that have a therapeutic effect.
- Small Molecule Drug Development Consulting Request consulting services related to small molecule development.
Food Safety & Regulations
- Anaerobic Plate Count Determine the total anaerobic bacteria present in a food or contact-surface sample.
- Total Coliform Testing Measure the bacterial content of a sample to assess food safety, efficacy of sanitation methods or handling practices.
- Total Viable Count (TVC) Estimate the total living microbial populations present in a food or beverage sample to guarantee product quality.
- Water Activity Determine water activity in consumer healthcare products involving a USP or FCC monograph.
In Vitro Assays
- Microbiology Study microbes and their role in human health.
Lab Supplies, Facilities, and Equipment
- Lab Equipment Installation & Calibration Install new or refurbish used laboratory equipment and calibrate to reference standards.
- Lab Equipment Maintenance & Repair Conduct repairs for laboratory equipment or routine and preventative maintenance.
- Lab Equipment Maintenance Agreement Design contracts for laboratory equipment evaluation and maintenance requirements.
Management Optimization & Development Strategies
- REACH Regulation Design Consultation for products within the European Union
Medical Communications
- Publication Writing Create further publication documents. Investigational device exemptions (IDEs) BLAs, MAA, PMA, eCTDs, informed consents, CMC and manufacturing reports, orphan drug designations (ODD), briefing books.
Other Specialty Toxicology
- Microbial Testing Test samples for microorganisms, identify species, do bioburden analysis and measure endotoxin levels (LAL).
- Raw Materials Testing Verify that raw materials are sterile and not contaminated by mycoplasma, virus or other microorganisms.
Pharmacovigilance
- GxP Compliance Monitoring Ensure products or services adhere to a set minimum standard.
Protein Sciences
- ELISA Detect the presence of antigens recognized by antibodies or find antibodies that recognize an antigen.
- Host Cell Protein Analysis Measure contamination of biologics with host proteins by using sequencing, chromatography and the LAL test.
- Protein Sequencing Determine the amino acid sequence of protein or peptide.
Regulatory Affairs
- Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.
Testing Services
- Accelerated Stability Determine shelf life of drug formulations by comparing API breakdown at elevated temperature.
- ASTM E2315: Time-Kill Procedure (Antimicrobial Testing Study) Assessment of Antimicrobial Activity Using a Time-Kill Procedure
- Bacterial Identification Testing Use biochemical and molecular methods to identify unknown microorganisms.
- Bacterial Reverse Mutation Assay Test whether a cosmetic product or ingredient causes DNA mutations in bacteria.
- Characteristic Testing Characterization of physical and chemical properties of raw materials
- CLSI M26-A: Minimum Bactericidal Concentration (MBC) Determine the lowest concentration of an antimicrobial agent that is lethal to the target bacteria in vitro.
Show all 18 in Testing Services
- Cosmetics Anaerobic Plate Count Determine the level of anaerobic bacteria present in a cosmetic or personal care product.
- Elevated Temperature Stability Determine the stability of a product at elevated temperature.
- Freeze-Thaw Testing Use freeze-thaw cycling to measure the long-term durability of cosumer products.
- ISO 11930: Preservative Test Evaluate the antimicrobial stabilization of a cosmetic product as per ISO 11930.
- Microbiological Sterility Testing Test the presence of viable microorganisms.
- Package Compatibility Tests Ensure that the consumer product is not adversely affected by the package components and vice versa.
- PAO Stability Trial Assess the stability of a consumer product under certain storage conditions.
- Raw Material Microbiological Testing Examples of which include Microbial Content using USP <61> and <62> and other standards, LAL Endotoxin, Ames Mutagenicity and Sterility.
- Real-time Stability Test Assure stability and physical integrity of consumer products in real-time conditions.
- USP 51 Cosmetic Preservative Efficacy Test Evaluate the antimicrobial stabilization of a cosmetic product as per USP 51.
- USP <61> Microbial Limits Test Determine whether a substance or preparation complies with an established specification for microbiological quality.
- USP <62> Microbial Limits Test Determine the presence or absence of specific microorganisms.
Other services
- IND Writing Receive assistance with materials for an IND application.
Service areas:
Biology
Chemistry
Where it operates
Sites by country, with the cities in each.
-
United States 14 sites
-
Puerto Rico 1 site
About this supplier
In the supplier's own words, as listed in the Scientist.com network.
Pace Analytical offers API services, microbiology services, manufacturing, and medical device testing.
- Professional associations
- BIOCOM, DCAT, MassBio
- Website
- pacelifesciences.com
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