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blue_bullet.gif (1048 bytes)Regulatory Services for Human Drugs and Medical Devices
blue_bullet.gif (1048 bytes)Non-Clinical Research and Development
blue_bullet.gif (1048 bytes)Human Drugs
blue_bullet.gif (1048 bytes)Clinical Trials and Clinical Development
blue_bullet.gif (1048 bytes)Clinical Data and Biostatistics
blue_bullet.gif (1048 bytes)Medical Devices and Diagnostics
blue_bullet.gif (1048 bytes)Veterinary Drugs
blue_bullet.gif (1048 bytes)GLP/GCP/GMP Audits and Study Monitoring
blue_bullet.gif (1048 bytes)Market Research and Development


Regulatory Services For Human Drugs and Medical Devices

SRS International Corporation specializes in (1) regulatory affairs and strategy, including negotiations with regulatory Agencies and the preparation and shepherding of regulatory submissions; (2) the design and conduct of product testing and evaluation programs for purposes of gaining regulatory approvals, developing new products and markets and defense against liability claims; and (3) the registration and listing of drugs and/or medical devices.  SRS International Corporation provides a single source for regulatory expertise.
  • Regulatory and product development strategy for human drugs, veterinary drugs and medical devices
  • US drug and medical device registration and medical device listing
  • Orphan Drug Regulations and strategy
  • Canadian regulatory affairs
  • IND, IDE, INAD, NADA, NDA, ANDA, 510(k), and PMA preparation and submission
  • Independent review and preparation of FDA submissions and responses
  • Preclinical and toxicology regulations and protocol design; study placement, monitoring; report writing and submission to FDA
  • Clinical trial program planning for human drugs and medical devices
  • Clinical trial database design and management and statistical analysis
  • Clinical trial uniform international registration strategy, budgeting and quality assurance
  • Labeling, certification, and exemption issues
  • Package insert regulations and design
  • Drug Master File regulations, preparation and maintenance
  • GLP, GCP, and GMP program design, implementation and audit


Non-Clinical Research and Development

SRS International Corporation provides a non-clinical research and development program designed with the clinical trial as the goal. Hence, the design and implementation are coordinated with the final product according to the latest in national and international regulatory guidelines. Since products require a wide range of non-clinical testing expertise, SRS International Corporation does not maintain a non-clinical testing laboratory but does maintain frequent and routine contact with all major non-clinical testing laboratories in order to provide our clients with the latest scientific experience and comparative cost estimates in this ever-changing industry. SRS International Corporation will design your protocol, place and monitor the study, review and/or write the report, and submit it to the FDA. Our research and development experience covers the broad spectrum of medical products and services listed below for emerging companies and Fortune 500 industries.

  • Standard drugs
  • Biotechnology
  • Drug delivery systems
  • Medical devices and diagnostics
  • Formulation development
  • Stability studies
  • USP testing
  • Teratology
  • Sub chronic and chronic toxicity
  • Acute toxicity
  • Reproductive and developmental toxicity
  • Neurological and behavioral toxicity
  • Genetic toxicology
  • Oncogenicity and carcinogenicity
  • Drug delivery systems
  • Pathology review
  • Analytical chemistry
  • Drug metabolism
  • Pharmacokinetics and pharmacology
  • Antimicrobial efficacy
  • US and international GLP and GMP design, monitoring, auditing

Human Drugs

The safety and efficacy of Pharmaceuticals, Diagnostics, Medical Devices and Biologics are under the jurisdiction of the FDA acting under the Food, Drug, and Cosmetic Act. This regulatory system is an extremely complex one, made even more complex with the addition of international harmonization guidelines and procedures. Only those with many years of experience and institutional memory can hope to deal with it effectively. SRS International Corporation will significantly reduce your uncertainties in dealing with the FDA's regulatory system. SRS International Corporation provides that perfect source to check it out and be sure. You can use SRS International Corporation's services for:

  • Consultation in product design & development
  • Non-clinical safety,toxicology, and pharmacology
  • Clinical program planning and trials management and monitoring
  • Clinical database design and management and statistical analysis
  • GLP, GCP, and GMP program design, implementation & audits
  • Regulatory strategy and implementation
  • Approval issues analysis
  • IND, IDE, NDA, ANDA, 510(k), and PMA, preparation & maintenance
  • Independent review and preparation of FDA submissions and responses to and from FDA
  • Data development strategy and implementation
  • Labeling and package insert issues
  • Drug chemistry
  • Bioequivalence issues

Clinical Trials & Clinical Development

SRS Health Care Group (SRS HCG) is a full service Contract Research Organization (CRO) and product development team. SRS HCG provides the entire spectrum of clinical development and regulatory approval services needed to bring new drugs, devices, and diagnostics to market. In the clinical trial arena, SRS HCG has designed, managed, monitored, and/or statistically analyzed data from Phase I through Phase IV studies. SRS HCG's hallmark in these studies is an efficiency, thoroughness, attention to detail and interaction with the sponsor that is often overlooked by larger CROs. Services offered by SRS HCG for clinical trials and clinical development include:

  • Protocol & CRF development
  • Conduct of trials for pharmaceuticals, diagnostics, & devices
  • Coordination, monitoring, & management of clinical trials
  • Data management & statistical analysis
  • Preparation of study reports for regulatory submissions
  • Drug safety monitoring board panel
  • Pharmacoeconomic studies
  • Integrated international registration preparation
  • Uniform international registration strategy, budgeting, and quality assurance
  • International investigator recruitment
  • R&D consultations
  • Drug Master File preparation and maintenance
  • Investigational and new drug submissions
  • 510(k), IDE, and PMA submissions

Clinical Data & Biostatistics

Clinical trial data management and biostatistical services are an integral part of the SRS International Corporation clinical trial program. SRS HCG offers experienced personnel, provides databases to deliver statistical analyses from Phase I and pharmacokinetics through Phases II, III, and IV, including submissions and summaries for INDs, NDAs, IDEs, 510(k)s, and PMAs. Among the services offered are:

Data Management

  • CRF design, tracking, & handling
  • Data review
  • Remote data entry/monitoring
  • Drug & disease coding (COSTART, WHO)
  • Automated data validation & query
  • Database design & creation
  • Data conversion
  • System/data security
  • Outcome studies
  • Post market surveillance

Biostatistics

  • Consultation & planning
  • Study design
  • Sample size calculation & multi-site randomization
  • Hardware & software validation
  • Customized reports

Medical Devices & Diagnostics

Medical devices and certain diagnostic equipment are regulated under the jurisdiction of FDA, acting under the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act and the FDA Modernization Act of 1997. FDA's implementation of these requirements has created an increasingly complex web of regulation which must be dealt with by device and diagnostic manufacturers. Added to these regulations are the newer International ISO standards and European Community standards. SRS International Corporation can significantly reduce your uncertainties in dealing with FDA's medical device regulatory system. SRS International Corporation  provides that perfect source to check it out and be sure. You can use SRS International Corporation's services for:

  • Regulatory and product development strategy
  • Review or preparation of 510(k)s, IDEs, and PMAs
  • Registering a new company and listing devices with the FDA
  • Identifying and obtaining FDA clearance for custom made orphan devices
  • Device testing strategy and implementation
  • GLP and GMP inspection
  • Literature search and summaries via direct link to the National Library of Medicine
  • Device labeling issues
  • Analytical chemistry and certification

Veterinary Drugs

The regulation of veterinary pharmaceutical product safety and efficacy is under the jurisdiction of the FDA. This regulatory system imposes a variety of requirements on producers of new and existing animal drugs.

SRS International Corporation will significantly reduce your uncertainties in dealing with the FDA's veterinary drug regulatory system. SRS provides that perfect source to check it out and be sure. You can use SRS services for:

  • Independent review of INADs and NADAs
  • Assistance with or preparation of INADs and NADAs
  • Supplemental NADAs
  • NADA files
  • Safety assessments and review of responses to and from FDA
  • Regulatory strategy and implementation
  • Data development strategy and implementation
  • Labeling, certification, and exemption issues
  • GLP and GMP assistance

GLP/GCP/GMP Audits and Study Monitoring

Audits for Good Laboratory Practices, Good Clinical Practice, and Good Manufacturing Practices, including monitoring of specific studies, form an integral part of any GLP, GCP, and GMP compliance program. The assurance that a study has been well conducted, 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, GCP, and GMP programs including the following;

  • In house, contract laboratory, or university GLP/GMP audits
  • In house, contract laboratory, or university monitoring
  • Hospital and clinic GCP audits and 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 Japan guidelines
  • Aid in auditing or monitoring a large volume of reports/studies
  • Standard Operating Procedure (SOP) development and review

Market Research and Development

Before a decision is made to manufacture and market a product, market research is essential. SRS International Corporation can aid your efforts in such research both in the USA and internationally to help determine those factors which will impact the economics and the timing of your new product and to help you obtain new licensing partners. Timelines are a most important aspect in the introduction of a new product and the knowledge of governmental regulations and their economic impact are ingredients of a step by step developmental plan that needs to be assessed early in any market research and product development plan. SRS International Corporation can aid you in these and other aspects of your market research and product development.

  • Determination of potential market share
  • Potential/actual competition
  • Step by step developmental and economic implementation plan
  • Identification of governmental regulations, registrations, and fees
  • Economic impact of governmental requirements
  • Identification of international concerns
 

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