About our partner
Our partner can provide a full range of support from product submissions to validation protocols to establishing all of the documentation to meet the guidelines for ISO and FDA QSR compliance. Our long time experience with the FDA regulations for diagnostics, pharmaceuticals, food and cosmetics, biologicals, and medical devices provides a practical and efficient approach to product submissions. Coordination of activities and generation of documents for FDA submissions is a significant part of our expertise and experience. We can also write all the SOPs for design control, manufacturing, Q.C., facilities, etc. We will identify guidelines for testing the products based on FDA accepted procedures. We can help to establish the "Quality" System throughout a facility in the following areas:
- Raw material testing and control
- Manufacturing SOPs and product history records
- Equipment and facilities validation protocols
- Process validation
- Quality Control procedures and release criteria generation
- Customer complaint handling and recall procedures
- Quality Systems Manual
- Labeling and quarantine SOPs
- Equipment SOPs
- Quality audit procedures
- Design validation and verification
- Sterility validation and verification procedures based on FDA recognized procedures such as the NCCLS
As a regulatory consulting organization, it is our responsibility to stay abreast of the FDA requirements for medical device, biologics, and pharmaceutical manufacturers, which change regularly. Our long time experience with the FDA regulations can provide a practical approach to FDA and ISO compliance.
Our partner provides a variety of technical and regulatory services to manufacturers of medical devices, diagnostics, food, cosmetics, and drugs. The following is a list of services we offer:
- Full FDA submissions [510(k), PMA, PLA / ELA, IDE, IND, ANDA, NDA] generated
- Clinical protocols and study monitoring performed for cosmetics, diagnostic, drugs, and biological products
- Assist in locating clinical study sites and qualifying investigators and medical personnel
- Data from clinical trials analyzed and report written
- Preparation of CMC sections for drugs, food additives, cosmetics, or biologics
- Submissions to USDA for animal diagnostics products
- Registration of environment products to the EPA
- Assist in designing and writing toxicology and microbiology studies, safety and efficacy studies, and feasibility study reports
- Documentation for process manufacturing and quality control testing written to comply with QSR/GMP/ISO and GLP
- Validation protocols written and performed for processes and equipment
- Contract product development technical support. Our own development of over 60 different diagnostic products using a variety of technologies in kit development for infectious diseases, autoimmune, hormones, drugs, or other disease conditions using ELISA, Rapid membrane, IFA, particle agglutination
- Manufacturing process evaluation of drug, biologics, diagnostic reagents and products. Our past experience in manufacturing provides practical assistance in production scale up and process problem-solving
- GMP and ISO audits performed to identify areas in which the GMP / ISO compliance may be weak or lacking. A report is submitted with recommendations for improvement
- Investigational Device Exemption (IDE) for clinical trials of medical devices and drugs
- Submit Various types of Biologic and Drug Master Files and DMFs for foreign device manufacturers
- Registration document packages for registrations outside the United States
- Our partner can provide acts as the U.S. representative to the FDA for Foreign companies
We have received FDA clearances for over one hundred (100) submissions for 510(k), PMA, IND, ANDA, and ELA/PLA/BLA for diagnostics, devices, drugs, food, cosmetics, and biologics. Familiarity with new techniques in monoclonal antibodies, recombinant antigens and peptides, and DNA PCR yields technical support for regulatory compliance and submissions.
As part of our service, we interface with the FDA reviewer in responding to questions and follow the submission through the clearance process. We have long-term working knowledge and experience with many of the FDA reviewers in the Center for Drug Evaluation and Research (CDER), Office of Device Evaluation (CDRH), specifically in the microbiology, immunology, chemistry, and hematology branches, and with the Center for Biologics Evaluation (CBER). We have prepared and presented Briefing Documents to FDA panel meetings for a variety of products and submissions.
Premarket Approval Applications (PMA) Including:
- Enzyme immunoassays for HIV and hepatitis markers
- Automated test system for detection of various cancer markers
510(k)'s for:
- In vitro Diagnostic test kits and Controls, Chemistry Tests, Immunological Tests, Hematology Tests and Infectious Disease Testing Systems. Test kits (60) for detection of various infectious diseases including Syphilis, CMV, EBV, HSV, Rubella, etc. Test kits for detection of various hormones including LH, HCG, FSH, etc. Test kits for Autoimmune Diseases such as ANA, MPO, CIC, GBM, ENA's, TG, etc.
REGULATORY AFFAIRS EXPERIENCE
Liaison with Federal, State, and Local Agencies
- Acted as the Official Correspondent and/or Responsible Head for companies
- Represented several international companies as U.S. Agent for regulatory affairs
- Handled recall and field correction activities including responding to the Mandatory Device Reporting Requirements and have assisted companies in responding to Warning Letters
Agencies routinely contacted include:
- Food and Drug Administration (FDA)
- Center for Biologics Evaluation and Research (CBER)
- Center for Drugs Evaluation and Review (CDER)
- Center for Devices and Radiological Health (CDRH)
- Centers for Disease Control (CDC)
Coordination and Monitoring of Clinical Trials
- Developed clinical trial protocols
- Set up clinical trials including selecting clinical investigators, securing needed equipment, ordering clinical trial materials, and preparing time and events schedules
- Monitored the progress of the trials and the reporting of the data
- Acted as liaison between the trial sites and the sponsor. Assisted the technical support staff of the sponsor companies in responding to technical questions during the trials
- Analyzed and reduced the data for inclusion in a clinical trial report and for submission to the FDA
Our partner can provide additional full range of technical and marketing services. Our practical and technical experience in product development and with manufacturing processes and equipment, plus our sales and marketing work in the medical industry, coupled with extensive regulatory experience provides our clients with the FULL range of support not found in traditional regulatory consulting organizations.