Life Sciences
Regulatory Approval and Product Safety
Broad toxicological support and regulatory strategy for new and existing biocides, specialty chemicals, food and beverage ingredients, food contact substances, and cosmetic ingredients.
Trinity Consultants’ SafeBridge group has extensive experience in the design, implementation, monitoring, and evaluation of the full range of toxicology (in vivo and in vitro), chemistry, environmental fate and effects, and human clinical studies to support regulatory strategies across a variety of industries.
The SafeBridge team offers expert toxicological support for the registration and approval of food and beverage ingredients and biocides, quality assurance of non-clinical toxicology studies, and regulatory submissions for the registration of industrial and specialty chemicals for global trade (e.g., REACH, TSCA). Our senior staff bring significant experience from working within our client sectors, allowing us to quickly understand client challenges and deliver customized solutions that help clients avoid typical regulatory pitfalls and accelerate their products to market.
We perform expert testing design and study monitoring services, including:
- Antimicrobials and specialty chemical regulatory support
- Food and beverage regulatory support
- Quality assurance
- Safety testing program management
- Scientific and regulatory affairs
How Else We Can Help
Related Services
Toxicology Services
Broad toxicological support around occupational exposure and product safety in the life science research and manufacturing environment.
Potent Compound Safety Certification
A groundbreaking tool for drug innovators and contract manufacturing organizations.
Industrial Hygiene
Extensive industrial hygiene support for the life sciences sector.
Hazard Communications and GHS Services
Expertise in chemical hazard classification, preparation of SDSs, and compliance with global hazard communication regulations.Our Results
Featured Projects
Trinity's SafeBridge Group Identifies Chloracne Source in Research Lab
SafeBridge investigated an outbreak of chloracne in a discovery lab at a top 5 pharma company, determined the novel compound responsible for the outbreak and recommended a safe course of remediation.
Pharmaceutical Leader Evaluates Safety and Quality of New Transdermal Patch
SafeBridge partnered with a global pharma company to design and perform extractables and leachables (E&L) testing and provide toxicological assessment of the results to assess the product’s safety and quality.Service Specifics
Regulatory Approval and Product Safety
1. Antimicrobials and Specialty Chemical Regulatory Support
We develop regulatory strategies for successful approval of antimicrobials, biocides, disinfectants, and other specialty chemical products, including:
- Coordinate data development and/or compensation, preparation of registration package submission
- Interface with regulatory agencies on behalf of clients
- Conduct read-across and/or QSAR assessments
- Prepare weight-of-evidence assessment reports
- Assign Global Harmonized System (GHS) classifications for new and existing Safety Data Sheets
2. Food and Beverage Regulatory Support
We provide regulatory support for food and beverage ingredients, including:
- Perform literature searches and reviews using the DistillerSR® system for systematic literature review, data gap analysis, safety and risk assessments using existing data or read-across and/or QSAR assessments, and exposure calculations supporting risk assessments
- Prepare application dossiers for food additives, flavoring ingredients, Generally Recognized as Safe (GRAS) materials, food contact substances, cosmetics and New Dietary Ingredients
- Coordinate Expert Panel reviews
- Assist clients in identifying, interpreting, and applying regulatory policy
3. Quality Assurance
Our senior consulting scientists and Registered Quality Assurance Professionals (RQAP-GLP) ensure compliance with Good Laboratory Practices (GLP) for all aspects of safety testing programs, from study design and contract research organization selection to study monitoring, in-life audits, and data and report reviews, ensuring scientifically accurate study results and successful regulatory submissions. Leveraging experience gained over hundreds of projects, our staff provides expert guidance for compliance with EPA, FDA, and OECD Good Laboratory Practices (GLPs) and FDA Good Clinical Practices (GCPs).
Our quality assurance services include:
- Inspection of testing facilities for GLP and GCP compliance
- Assistance with GLP compliance program design and implementation including training for sponsors and testing facilities
- Auditing support (remote and onsite) for all toxicology (in vivo and in vitro), chemistry, environmental fate and effects, and human clinical study designs, including protocol reviews, raw data audits, report audits, critical phase inspections, and archiving
4. Safety Testing Program Management
A well-executed testing program can be the difference between a smooth path to regulatory approval or one that is delayed by regulatory hurdles. Our comprehensive safety testing management services ensure the scope of testing is scientifically justified and addresses specific data needs to support regulatory objectives.
Before testing begins, we evaluate regulatory requirements, assess data gaps, and develop approaches to address mechanistic and mode of action questions. We review published literature and/or prepare data waiver requests when scientifically justified. We assist in laboratory selection, coordinating bidding and evaluating GLP or GCP compliance of the selected facility.
During testing, we provide expert guidance and oversight on the scientific aspects of studies, from protocol development to monitoring study conduct, including onsite scientific evaluation of key study milestones. We ensure that study timelines are met to satisfy regulatory deadlines and provide comprehensive third-party quality assurance throughout the testing program.
Throughout testing and upon study completion, our scientific team conducts periodic review of data to monitor treatment-related effects, identify any uncontrolled variables, and recommend corrective action when needed.
At study completion, we closely review reports and raw data to ensure that the reports accurately reflect the data, comply with GLP or GCP, and that conclusions are scientifically valid and reflect the study objectives.
5. Scientific and Regulatory Affairs
We provide expert scientific and regulatory guidance and knowledge to support your business objectives. Our extensive experience enables us to shorten the timeframe typically associated with regulatory approval, often compressing time to market. We interface constructively with regulatory agency contacts in the U.S., Canada, and Europe on scientific and technical issues. We are especially effective at clarifying and negotiating data requirements, preparing regulatory submissions, presenting weight of evidence safety evaluations, and facilitating effective meetings. In many cases, our guidance or interaction with regulatory agencies has resulted in a reduction in the number and/or magnitude of the studies that are required for ingredient approval or product registration.