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Registration and Regulatory Services
SRS International Corporation specializes in (1) regulatory affairs and strategy,
including negotiations with regulatory agencies and the preparation and shepherding of
regulatory submissions; and (2) the design and conduct of product testing and evaluation
programs for purposes of gaining regulatory approvals, developing new product uses and
markets, and defense against liability claims. SRS International Corporation provides a single source for regulatory
expertise.
- U.S. registration and regulatory affairs for new actives and new uses
- Canadian registration and regulatory affairs
- Preparation/regulatory management of petitions for tolerances, and tolerance exemptions,
direct and indirect food additive regulations, and GRAS affirmation
- Design, management, conduct, monitoring, and data evaluation/interpretation for
laboratory and literature-compilation studies in: toxicology, chemistry, environmental
effects, animal and human metabolism and pharmacokinetics, human patch testing, mechanism
of action, and epidemiology
- Toxicity/safety evaluations and risk and exposure assessments
- Toxicology and product registration expert witness and litigation support services
- MSDS preparation
Toxicology Services
SRS International Corporation does not maintain its own animal facilities. Experience has shown that it is more
effective for our clients to use SRS International Corporation's network of laboratories, which are periodically
evaluated by SRS International Corporation. Within this network and under SRS
International Corporation's design, management, monitoring, and
evaluation of results, the following study types are conducted:
- Acute - oral (rats, mice, dogs, monkeys); dermal (rats, rabbits); inhalation
(rats, mice)
- Delayed hypersensitivity and dermal sensitization in Guinea pigs and
rabbits
- 14 - 28 Day repeat exposure - oral (rats, dogs, monkeys); inhalation
(rats, mice); dermal application (rats, mice)
- 90-Day - oral/dietary (rats, mice, dogs); dermal (rats, rabbits); inhalation
(rats, mice)
- Chronic - oral/dietary in the rat (2-year), dog (1-year), monkey (6 mos.
and up); inhalation (rats, mice); dermal (rats, rabbits)
- Oncogenicity in the rat (2-year) and mouse (18-month)
- Reproductive Effects, multi-generation,
rat
- Teratogenicity and developmental effects in the rat, mouse, and rabbit
- Special routes of exposure: intravenous, intraperitoneal, subcutaneous
- Mini-swine studies
- Pharmacokinetics: Absorption, distribution, metabolism and excretion
(ADME)
- Neurotoxicity (acute and subchronic)
oral, dermal, or inhalation
- Gene Toxicity: Gene Mutation, Chromosome Aberrations, and non-Specific Gene
Damage
- Avian acute oral/dietary toxicity and reproduction
- Fish and aquatic invertebrate toxicity: acute and life-cycle studies
- Mechanism of Action and other Specialized Studies In Vitro and In Vivo
Risk and Exposure Assessment
SRS International Corporation's approach to conducting exposure and risk assessments is based on looking carefully
at all of the elements, both facts and assumptions, which enter into such assessments. We
look at the selection of the data base for hazard identification and quantitative risk
modeling, the nature and quality of the exposure data, the appropriateness of the exposure
and risk models which may be used in the context of the case at hand, and whether the
typical default assumptions are reasonable or supportable assumptions for the specific
matter at hand. We believe that SRS International Corporation brings some very key strengths to this area:
- SRS International Corporation's principals have been intimately involved in the development and evolution of risk
assessment policies and have a tremendous in-depth understanding of this area
- SRS International Corporation's principals are always accessible to the client and have a hands on
involvement in any exposure assessment, risk assessment or toxicological evaluation which
we conduct
- SRS International Corporation's principals have extensive experience in dealing with the media and the public on
risk assessment, risk characterization, and risk perception
SRS International Corporation's risk assessment and exposure services include:
- Multi-model quantitative carcinogenic risk estimation
- Benchmark dose based safety and risk assessments
- Pharmacokinetics and target tissue dose based modeling
- Comparative risk analyses
- Maximum exposure and sensitive individual based exposure assessments
- Exposure measurement, sampling, and dosimeter studies
- Evaluation and validation of data bases
- Analysis of effects of uncertainties in assessments
- Evaluation of interspecies scaling factors
- Mechanistic and molecular biology factors
Analytical Chemistry & Certification
The range of analyses required for environmental assessments, FDA extraction studies
for food contact materials, pharmacokinetics, personal products, and devices requires not
only good protocol design and execution but expertise in interpretation to assure that all
concerns are addressed. SRS International Corporation can provide the sophisticated knowledge needed in key client
industries: pharmaceuticals, agricultural chemicals, industrial chemicals, food and feed,
medical devices and personal products. You can rely on this expertise for:
- Product chemistry and QA analyses
- Residue analyses in plants, animals, food/feed and environmental samples
- Method development, internal validation, and independent laboratory validation
- Biological analyses and biochemical methods
- Custom design of analytical and extraction protocols
- Placement and monitoring of analytical studies
- Identification and analytical assessment of manufacturing
contaminants/residues
Agricultural Chemicals and Crop Protection Agents
Agricultural chemicals and crop protection agents (i.e., Insecticides, Miticides,
Fungicides, Herbicides, Plant Growth Regulators; Microbial and Biochemical Pest Control
Agents; etc.) provide for increased efficiency in agriculture, crop protection, and
control of destructive and/or disease bearing pests. U.S. EPA and other, corresponding,
national authorities have established data requirements and registration procedures for
these products to assure that in providing these societal benefits such products do not
produce unreasonable adverse effects on health or the environment.
SRS International Corporation will help you deal effectively and confidently with these regulatory authorities in
the Americas and Europe. SRS International Corporation provides the perfect, single source for international data
development and regulatory services such as:
- Preparation of or independent review of registration applications, label amendment or
expansion applications, international dossiers, and tolerance or tolerance exemption
petitions
- Experimental use permits
- Independent review of responses and approaches to regulatory agencies
- Data development strategy
- Regulatory strategy
- Field studies for product performance, plant
metabolism, and residues
- Laboratory toxicology, chemistry, and animal
metabolism studies
- Environmental fate and effects studies
- Exposure studies and assessments
- Safety and risk assessments
- GLP programs and audits
- Responses to data call-in and other information / data requests
- Inerts issues and clearances
- Ground and surface water issues
- FIFRA amendment and policy issues
- FGPA requirements and issues
Food And Food Additives
Modern food technology has made available a wide range of foods with longer shelf life,
lower fat content, less potential for microbial spoilage, and lower costs to the average
consumer. An important part of modern food technology are the products added to food to
give a desired effect (direct food additives) and indirectly imparted to food during
processing, packaging, distribution and storage (indirect additives). In the U.S., these
additives are regulated by FDA.
SRS International Corporation's experience and know-how will help you deal effectively and confidently with FDA's
food additive regulatory process. SRS International Corporation provides the perfect, single source for data
development and regulatory services such as:
- Preparation of or independent review of direct and indirect food additive petitions,
color additive petitions, threshold-of-regulation submissions, "no objection"
letter request, GRAS affirmation petitions, and self-GRAS programs
- Acceptable Daily Intake (ADI) and other safety assessments for the intended use of an
additive
- Dietary Exposure Assessments
- Threshold of Regulation Petitions
- No Objection Letters
- Independent review of responses to and from FDA
- Regulatory strategy
- Data development strategy
- Dietary exposure, safety and risk assessments
- Environmental impact assessments (Section H) for food additive petitions
- Constituent policy issues
- Toxicology, chemistry, and additive migration studies
TSCA Regulated Products
Products regulated under the U.S.'s Toxic Substances Control Act include virtually
every chemical and biotechnology product which is not specifically regulated as a
pesticide, food additive, cosmetic ingredient, or drug. TSCA requirements are becoming
increasingly complex as U.S. EPA increases its new chemical data requests and testing
requirements on existing products.
SRS International Corporation's experience and know-how will help you deal effectively and confidently with EPA's
TSCA regulatory process. SRS International Corporation provides the perfect, single source for data development and
regulatory services such as:
- PMN, LVE, SNUN, Polymer exemption, and other submissions
- Responses to and negotiations over proposed 5(e) Consent Orders
- Responses to Section 4 Listings by the ITC and protocol design issues
- Regulatory strategy
- Data development strategy
- Risk and safety assessments
- Exposure assessments
- Toxicology, chemistry, and environmental fate and effect studies
GLP/GMP Audits & Study Monitoring
Audits for Good Laboratory Practices and Good Manufacturing Practices, including
monitoring of specific studies, form an integral part of any GLP or GMP compliance
program. The assurance that a study has been well conducted and that a manufacturing process
is well controlled is not only a regulatory compliance issue, but makes good business
sense. SRS International Corporation can aid you in designing, implementing, or validating GLP and GMP programs
including the following:
- In-house, contract laboratory, or university GLP/GMP audits
- In-house, contract laboratory, or university GLP study monitoring
- Supplemental GLP audits/monitoring to in-house programs
- GMP inspections to identify specific problems
- Resolution of GMP problems
- Custom designed audits for specific procedures/endpoints
- GLP/GMP audits according to US, OECD, ISO, and Japanese guidelines
- Aid in auditing or monitoring a large volume of reports/studies
- Standard Operating Procedure (SOP) development and review
International Services
With the development of international regulatory organizations and international
trading blocs, the international scope of product development constitutes a high priority
goal. As its name implies, SRS International Corporation interfaces worldwide on behalf of its
clients to speed the introduction of their products into the international marketplace.
SRS International Corporation can significantly reduce the redundancy of data, the cultural interpretations and
nuances, and other problems that tend to delay the introduction of a product in a foreign
country. Extensive experience in Asia as well as the Western world makes SRS
International Corporation the perfect
partner to ease the introduction of your product internationally.
- Interaction/services for the United Nations and World Health Organization
- Services for foreign governments
- Market research
- Product development
- Study placement and monitoring
- Guideline compliance including ISO and European Community guidelines
- Foreign language to American English scientific translation or
rewriting
- English to foreign language translations of scientific data/reports
- Registrations, listings, and international
dossiers
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