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Abphina, LLC
Abphina, LLC is listed as a small business research supplier in the Scientist.com network, with 2 sites in 1 country.
View Abphina, LLC on Scientist.com
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Sites
2
Countries
1
Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Small business
Chemistry, Manufacturing and Controls (CMC)
- Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
Clinical Consulting
- Biostatistics Consulting Apply statistical theory and mathematical principals to research
- Clinical Consulting Provide high quality data, on time and within budget, while maintaining the flexibility in delivering personalized services.
- Clinical Development Planning Complex document that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity.
- Clinical Protocol Design & Development Creation of clinical protocol document which details how a clinical trial is designed, relating to to the methodology, hypothesis, and operation of clinical trial to ensure the safety of the patients is...
- Data & Risk Management Determine the extent of the risk and the reliability of the data used to access the aforementioned risk.
- IND Writing Consulting Consulting for an Investigational New Drug Application
Show all 8 in Clinical Consulting
- 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
- Clinical Research Services Determine the safety and effectiveness of medications and medical devices.
- Clinical Trial Design Develop study-related protocols, case report forms (CRFs) and database tools for records management.
- Clinical Trial Risk Management Plan that maintains treatment quality throughout lifecycle and improve decision making.
- 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.
Commercial Consulting
- Portfolio Management Manage a portfolio of projects in early-stage drug discovery and provide factors that determine the success of the proposed portfolio.
Show all 42 services
Data Science/Bioinformatics
- Discovery Data Management A process that includes acquiring, validating, storing, protecting, and processing required data to ensure the accessibility, reliability, and timeliness of the data for its users.
Market Access
- Marketing and Commercialization Identify, promote and prove the value of a particular drug to key stakeholders.
Medical Communications
- Medical Publications Make clear and accurate presentations of scientific and technical data.
- Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
- Protocol and Study Reports Write protocol and study reports, specifically relating to the drafting, writing, and editing of Clinical Safety Reports.
Pharmacovigilance
- GxP Compliance Monitoring Ensure products or services adhere to a set minimum standard.
Regulatory Affairs
- Medical Labeling Design and create medical labels that accurately reflect purpose, precautions and other information.
- Patient Risk Management Identify, contain, and manage risks related to patient safety.
- Period Benefit Risk Evaluation Report (PBRER) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
- Periodic Safety Update Report (PSUR) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
- Post-authorization Safety Studies Research efforts conducted after a drug has been approved for market to monitor its safety profile in the general population. These studies aim to identify, characterize, or quantify potential adverse effects...
- Risk Benefit Assessment Determine ratio of treatment risk to the potential benefits.
Show all 7 in Regulatory Affairs
- Risk Evaluation & Mitigation Strategy (REMS) Evidence required by FDA to support the benefit of treatment outweighs the risks. Purpose of REMS is to prevent, monitor, and manage serious risk by informing, educating, and reinforcing actions to reduce frequency...
Scientific Data Services
- Bioinformatics Bioinformatics is a powerful method of storing, retrieving and analyzing biological data.
- Data and Text Mining Derive structured data from free text in order to become accessible for data-mining algorithms.
- Data Curation Organize and integrate data collected from various sources to ease data discovery and retrieval.
- Data Infrastructure Design and deploy an information management solution suited to users' specific needs.
- Database Integration Convert bioinformatics results from multiple data sources (DSs) into a single operational format.
- Machine Learning/ AI Predict and model an outcome (e.g. disease progression) based on input variables (i.e. features.)
Show all 9 in Scientific Data Services
- Ontology Mapping Assign given ontologies to source data.
- Scientific Data Visualization Exploration and reporting of data by means of graphs and plots.
- Small RNA Gene Expression Quantify and analyze miRNA, piRNA, siRNA as well as other small nuclear RNAs from small-RNA-seq raw input data sets.
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.
- Real-time Stability Test Assure stability and physical integrity of consumer products in real-time conditions.
Other services
- IND Writing Receive assistance with materials for an IND application.
- NDA Writing Receive assistance in the NDA application process.
- New Request
Where it operates
Sites by country, with the cities in each.
-
United States 2 sites
About this supplier
In the supplier's own words, as listed in the Scientist.com network.
- Professional associations
- AAPS, BIOCOM
- Website
- www.abphina.com
Work with Abphina, LLC on Scientist.com
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