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A&O Pharma GmbH
A&O Pharma GmbH is listed as a small business research supplier in the Scientist.com network, with 3 sites in 1 country.
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Sites
3
Countries
1
Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Small business
Chemical and Compound Analysis
- Analytical Separations and Purification Analytical Separation and Purification of compound/molecule.
- 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.
- Compound Integrity Analyze the identity and purity of small molecule drug candidates.
- Dissolution Profiling Measure release of API from formulation (tablet or capsules) under GMP guidelines.
Show all 15 in Chemical and Compound Analysis
- Gas Chromatography Gas chromatography is an analytical technique that separates, identifies, and quantifies compounds in a mixture
- Headspace Gas Chromatography Analyze volatile organic compounds (VOCs) partitioned above the liquid/solid phase of a sample.
- High Resolution MS Elucidate the sequence and structure of peptides, proteins, biomarkers and organic compounds.
- Liquid Chromatography Separate substances using a mobile and stationary phase.
- NMR Structure Determine molecular structure, identify chemical impurities and validate sample integrity.
- Optical Rotation Distinguish between optical isomers as well as between natural versus man-made compounds.
- Photostability Measure drug degradation rates after exposure to various light sources.
- Physicochemical Analysis Physicochemical Analysis of material or preparation evaluating (e.g.) particle size, composition, or compound structure.
- Size Exclusion Chromatography Separate and identify analytes based on their molecular size.
Chemical and Compound Testing
- Product Testing Ensure product quality standards are met.
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 and drug product storage and release API and drug product storage and release
- API manufacturing process development, tech transfer and validation API manufacturing process development, tech transfer and validation
- 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.
Show all 23 in Chemistry, Manufacturing and Controls (CMC)
- API/DP specific test methods API/DP specific test methods (e.g., stability indicating HPLC assay and purity)
- Bulk Raw Materials Acquire raw materials in large volumes at wholesale pricing.
- Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
- Clinical supply management Clinical supply management
- Coating Analysis Evaluate the coat properties of pharmaceuticals, polymers and other finished materials.
- Compendial test methods Run Compendial test methods (e.g., KF)
- 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.
- 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.
- Formulation Services Assistance when determining the look, texture, fragrance of a product with compatibility with product packaging, knowledge of competitive performance traits and product shelf life.
- ICH-compliant stability testing Perform ICH-compliant stability testing
- Impurities in Drugs Risk Assessment Create a risk-based control strategy to determine any toxic elemental impurities that may be present in human medicines.
- Product Insert Packaging Use product insert or leaflets to inform patients, satisfy regulatory requirements or extend a coupon offer.
- Raw Materials & Ingredients Purchase raw materials, ingredients, or chemicals for personal care, cosmetic, consumer health, and beauty products and substances.
- Thermo Scientific iCAP Q ICP-MS Expand your analytical capabilities with this complete trace elemental analysis solution for your high-throughput lab.
Show all 73 services
Clinical Consulting
- Clinical Trial Consulting Consulting services for Clinical trials.
- IND Writing Consulting Consulting for an Investigational New Drug Application
- Product Testing Consulting Expert advice to evaluate the effectiveness, quality, and legitimacy of a given item or good.
- 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.
- Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.
Clinical Trials
- BioAnalytical Laboratory Services Bioanalytical laboratory services provide essential testing to quantify drugs, metabolites, and biomarkers in biological samples (blood, urine, tissue) to support preclinical and clinical drug development
- Comparator Drug Sourcing Streamline new drug development and clinical trials by comparing the efficacy of an experimental drug to a comparator drug.
- IP Import/ Export Licensing Receive assistance with intellectual property import and export licensing.
- IP Labeling Proper IP labeling guidelines are produced by the Food and Drug Association. Based on the compound or product in need of proper labelling there are guidelines that can be followed.
- IP Packaging Proper packaging of pharmaceutical products and goods is crucial to ensure the validity and quality of the product being supplied. Proper investigational product packaging is aided by the use of quality...
- IP Returns & Destruction Return the used and unused IP to the clinical trial sponsor for destruction, as well as send the used and unused IP for destruction in accordance with institution policy, or the standard operational procedure. Theses...
Show all 12 in Clinical Trials
- IP Shipments & Resupply IP shipments and resupply aid in the management of shipping of clinical trial material from warehouses to clinical sites, or vice versa. Shipping and resupply aids in restocking, drug orders, shipment tracking...
- IP Storage IP storage protocols are specifically defined by the U.S. Pharmacopeia, Japanese Pharmacopeia, and the European Pharmacopeia that specifically define the proper storage and transportation conditions...
- Phase 1-3 Studies Design phase 1-3 studies that seek to identify if a drug is safe, effective, and more efficient than other available treatments on the market.
- Post-Marketing (Phase 4) Studies Conduct phase 4 studies for confirming unrecognized safety issues, investigating possible hazards or establishing the expected safety profile of a veterinary medicinal product under market conditions.
- QMS- Quality Management Systems Structured framework of processes, procedures, and responsibilities designed to achieve quality policies and objectives
- Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Discovery Chemistry
- LCMS Analysis Physically separate substances using liquid chromatography and mass spectrometry.
- Method Development and Validation Develop and validate methods for synthesis and scale up of drug candidates.
- Near-infrared (NIR) Spectroscopy Non-destructive, fast analytical method, that measures molecular overtone and combination vibrations, commonly used for rapid, in-line, or on-line composition analysis
- Trace Elemental Analysis Identify organic and inorganic elements in foods and dietary supplements at ppm to sub-ppt levels.
- UV and IR Profiling Analyze the integrity of a compound or large biomolecule.
Drug Development
- Chemistry, Manufacturing and Controls (CMC) Consulting Consultant services related to the development of pharmaceutical and biopharmaceutical drug products that are consistently effective, safe and high quality for consumers.
- Consulting Services Work with consultants who provide expert advice in various areas of research and technology.
Medical Communications
- Gap Analysis Compare the actual performance of an organization or corporation with potential or desired performance, as ways to effectively analyze resource management or allocation.
- Quality Control/ Quality Assurance Documents Develop quality control or quality assurance documents.
- Regulatory Audit Supports Providing documentation, responses, and expert assistance to ensure preparedness and successful outcomes during inspections by regulatory bodies.
- Regulatory Submissions and Compliance Draft, format, and submit documents to Pharmaceutical approval agencies according to documentation and guidelines. This includes documents such as NDAs, INDs, SUSARs, AE reporting, RMPs, and PSURS.
Pharmacovigilance
- GxP Compliance Monitoring Ensure products or services adhere to a set minimum standard.
- IND/CTA Authoring and Publishing Services IND/CTA authoring and publishing services involve preparing, compiling, and submitting Investigational New Drug (IND) applications or Clinical Trial Applications (CTA) to regulatory authorities, ensuring compliance...
- Regional Regulatory Consulting Regional regulatory consulting provides expert guidance on local regulatory requirements and processes to help companies navigate and comply with the specific rules and standards of different geographical regions...
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.
- Elevated Temperature Stability Determine the stability of a product at elevated temperature.
- Website
- www.aopharma.de
Where it operates
Sites by country, with the cities in each.
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Germany 3 sites
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