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Research supplier
G&L Scientific
G&L Scientific is listed as a mid sized business research supplier in the Scientist.com network, with 2 sites in 2 countries.
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Sites
2
Countries
2
Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Mid sized business
Animal Science and Welfare Audits
- Vendor Audits/Qualifications vendor audits for non-GLP and GLP nonclinical CROs throughout the US and Canada.
Chemical and Compound Analysis
- Chemical Stability Measure the stability of small molecules in solution.
Chemistry, Manufacturing and Controls (CMC)
- Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
- Drug Product Stability Use accelerated stress conditions to determine degradation pathways and identify manufacturing issues.
Clinical Consulting
- Biostatistics Consulting Apply statistical theory and mathematical principals to research
- 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...
- Clinical Trial Consulting Consulting services for Clinical trials.
- Clinical Trial Feasibility Request services related to Clinical Trial Design and feasibility.
- Clinical Trial Recruitment Recruitment, enrollment and retention of patients for clinical trials.
Show all 10 in 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.
- Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.
- Support Staff Recruitment Recruit nurses, clinical staff, certified clinical research coordinators and research support staff.
Clinical Trials
- Bioequivalence Studies Assess the expected biological equivalence of two proprietary preparations of a drug.
- Case Report Monitoring & Auditing Ensure the adequate collection and traceability of clinical data in preparation for review by the FDA.
- 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.
- Consumer Healthcare Product Trials Conduct clinical research to ensure the safety and efficacy of consumer healthcare products used for oral care, skin care, nutrition, and hair care.
- 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.
Show all 12 in Clinical Trials
- 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.
- Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
- Regulatory Operations Ensure that all specific regulatory documents are published and properly organized before submission.
- Site Monitoring Maintain oversight over participant's health during a clinical trial.
- Site Selection Select clinical trial sites with clinicians who recruit, enroll, treat and evaluate trial patients.
- Study/Site Feasibility Study Explore and test study practicality.
Show all 60 services
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.
Data Science/Bioinformatics
- Biostatistical Design Use statistics to ensure appropriate pre-clinical and clinical study design.
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.
- 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.
- Target Validation Consulting Help to demonstrate that modification of target activity has potential therapeutic benefits.
- Toxicology Consulting Use models to assess acute and sub-acute toxicity as well as chronic and sub-chronic toxicity.
Effectiveness
- Bioequivalence Studies for Veterinary Drugs Assess the expected biological equivalence of two proprietary preparations of a veterinary drug.
General in vivo Toxicology
- General Toxicology Use in vivo models to assess acute and sub-acute toxicity as well as chronic and sub-chronic toxicity.
Management Optimization & Development Strategies
- OECD Regulatory Development Consultation in safety testing, chemical notification and registry within OECD.
Market Access
- Emerging Market Opportunities Analyze risks and opportunities in new markets and ensure patients have timely and continued access to new treatments.
- Market Access Materials Find general strategies and methods used to market a pharmaceutical product or device.
- Market Research & Business Intelligence Run market feasibility studies, establish customer needs, improve product performance and analyze competition.
- Pricing Strategy Develop value story tailored to a payer audience that will determine the appropriate price for treatment.
Medical Communications
- Medical Literature Reviews Systematic searching, appraisal, and synthesis of published scientific literature to generate evidence-based reports on a specific topic, disease, or treatment.
- 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.
- 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.
- Quality Control/ Quality Assurance Documents Develop quality control or quality assurance documents.
Show all 8 in Medical Communications
- 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.
REACH Services
- Dossier Prep. and Consultancy Assistance with creation of a regulatory document that contains all the Clinical, non-clinical, and CMC information of a pharmaceutical product to be approved, registered, or marketed within a specific country.
Regulatory Affairs
- Life Cycle Management Plan and strategy of the data collection and information throughout the different phases of product development (portfolio assessment, pre-clinical trials, clinical trials, pre-authorization, post-authorization, and RWE)
- 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
- 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.
Regulatory Consulting
- Environmental Fate and Ecotoxicology Data Review Identify relevant endpoints for fate and behavior (metabolism and excretion, degradation and soil adsorption) and toxicity (soil organisms, aquatic organisms, and dung fauna) of animal health products.
- Environmental Risk Assessment Conduct EU and US Environmental Assessment (ERA/EA) phases one and two according to VICH guidelines.
- Toxicology Data Review Identify relevant toxicological endpoints for “No Observed (Adverse) Effect Level” (NO(A)EL) or “Lowest Observed (Adverse) Effect Level” (LO(A)EL).
Scientific Data Services
- Data Quality Framework Manage data quality issues to maintain good quality data outputs.
Other services
- IND Writing Receive assistance with materials for an IND application.
- NDA Writing Receive assistance in the NDA application process.
Where it operates
Sites by country, with the cities in each.
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United Kingdom 1 site
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United States 1 site
About this supplier
In the supplier's own words, as listed in the Scientist.com network.
We provide consulting, staffing and support services for Clinical Research and Regulatory Affairs.
- Professional associations
- BioFlorida, Consumer Healthcare Products Association (CHPA)
- Website
- www.gandlhealth.com
Supplier diversity
SAM.gov small-business designations
Minority-owned
US small-business federal-contractor designation, self-certified in the U.S. federal System for Award Management (SAM.gov). Coverage is limited to matched U.S. small-business suppliers, so an absent designation is not evidence of its absence.
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