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Schiff & Company offers services in the following areas:
- Regulatory Affairs
- Good Manufacturing Practices
- Clinical Services
- Biostatistics
- Data Management
- Food and Cosmetics
An experienced project manager supervises your project and coordinates all appropriate Schiff & Company resources. This team leader is your primary contact for all information and provides you with frequent and comprehensive reporting on the status of your project.
Your product development program will benefit from our years of experience and wide range of expertise. Your submissions will benefit from our knowledge in preparing all documentation in a clear, concise and technically accurate manner.
Schiff & Company has the resources and technology to meet your regulatory and clinical requirements at any point in the product development process.
Regulatory Affairs
Schiff & Company handles all aspects of the regulatory process in product development -- from preclinical to post-approval.
We maintain constant surveillance over the rapidly evolving U.S. regulatory policies and monitor international trends through our affiliate offices.
We assist companies bringing to market both prescription and OTC drugs and biologies, devices and in vitro diagnostics
Services Include:
- Define Regulatory Requirements -- develop global regulatory strategies to streamline and expedite approvals. We prepare and file INDs or IDEs and arrange for and participate in meetings with regulatory officials.
- Prepare All Filings -- IND, NDA, PLA/ELA, IDE, PMA and 510(k). In particular, our experience includes the assembly of NDAAs and PLA/ELAs. We assure that user fee monies, when applicable, are submitted prior to filing. We also prepare DMFs, annual reports and data packages for pre-approval conferences and advisory committee meetings
- Follow Up --- handle post submission questions.
- Establish Medical Device Reporting Systems
- General Consultancy -- with senior management each having more than 20 years of experience, we can provide you with advice on a wide range of regulatory issues on an as needed basis.
Good Manufacturing Practices
Schiff & Company has extensive experience in obtaining FDA approval of manufacturing and distribution sites in the U.S. and overseas. We have expertise in working with:
- Bulk Processes
- Pilot, Clinical and Manufacturing Operations
- Equipment
- Solid and Liquid Dosage Forms
- Parenterals
- Purified Water
- Sterility Assurance
- Support Systems and Utilities
Services Include:
- Audits and Pre-Approval Inspections -- a Complete Review of Facilities, Work, Materials Flow and Documentation
- Validation -- Process, Cleaning Computer, Methods
- Validation Protocols -- Development and Data Analysis
- SOPs -- we review and/or write SOPs for GMP/GCP/GLP
- Vendor Certification
- In-House Training in GMP and Quality
- FDA Liaison
Clinical Services
Schiff & Company has broad experience in planning and implementing clinical development projects for drugs, biologics, and devices.
It includes Phase I, II, III, IV and Rx-to-OTC switch clinical trials in most therapeutic categories. Projects have ranged from a single-center trial with a few patients to a moderately-sized studies with several thousand patients.
Services Include:
- Development Strategy -- gain a complete understanding of your needs, including indications, timeliness and resources to assess scientific validity and regulatory acceptability. Prepare the pre-IND and end of Phase II documents.
- Protocol and Forms Development -- develop concise documents in strict accordance with regulatory guidelines including investigator brochures, case report forms and informed consent forms.
- Investigator and Site Selection -- select appropriate researchers and locations for your study. We maintain a continuously growing list of investigators in many therapeutic areas and conduct a site audit prior to the selection of any site.
- Study Management -- handle investigator payments, arrange for drug supply packaging and labeling and monitor the drug supply.
- Monitoring -- our clinical Research Associates keep in regular contact with study sites and insure strict compliance with GCP guidelines. Status reports are provided after each visit. Clinical sites are prepared for FDA inspections. We follow-up all adverse events according to FDA guidelines and your specific needs.
- Medical Writing -- our staff of writers, produces clinical reports (fully integrated with biostatistics as required), manuscripts for publication, monographs and all regulatory submissions.
Schiff & Company's staff has experience in a wide range of therapeutic categories:
- Anti-infectives
- Cancer
- Cardiovascular
- Dental
- Dermatological
- Gastrointestinal
- InVitro Diagnostics
- Neurological
- Ophthalmological
- Respiratory
- Rheumatological
Biostatistics
Our biostatistics group provides you with services on a standalone basis or as part of a complete clinical development program.
Services Include:
- Consultation on Study Design
- Selection of Sample Size
- Establishment of Randomization Codes
- Statistical Analyses, Adverse Events COSTART Coding and Use of SAS Programming
- Dose-Response and Special Patient Population Analyses
- Tables and Graphs
- Statistical Reports
- Pharmacokinetic/Pharmacodynamic Analyses
Data Management
Our data management staff works with our biostatistics group to insure accurate data transfer.
Services Include:
- Database Design - customized to your needs
- Case Report From Coding
- Data Entry and Management
- Daa Editing and Cleaning
- Database Quality Assurance Audits (100% Verification)
- Data Reporting and Transfer (SAS or ASCII)
- Data Listings
- Preparation of Electronic Files of Statistical Data in SAS Data Sets and/or Lotus/Excel/Access Database Files
Food And Cosmetics Division
The Food and Cosmetics Division is equipped to handle all your international regulatory needs.
Services Include:
- Food and Color Additive Petitions
- Nutrition Labeling
- GMPs, LACF, HACCP
- Import/Export
- Recalls
- Complaint Management
Our staff plans regulatory strategy, conducts human feeding studies and other clinical studies and does technical and medical writing, statistical analysis and reports.
The Food and Cosmetics Division also conducts research and development. In its own laboratories, it designs and creates food and cosmetic products for commercial use. From concept to pilot plant, production and launch, we help with your product development activities.
Robert Schiff
Schiff & Company founder and CEO is Robert Schiff, an accomplished business executive and scientist with many years of experience in the health care industry. He has authored over 40 publications and holds several patents on medical products. Dr. Schiff received his B.S. from the City College of New York, M.S. from Iowa State University, and Ph.D. from the University of California at Davis. He is a member of the Graduate Business faculty at Farleigh Dickinson University, also lectures on International Business and is board certified in Regulatory Affairs (R.A.C.) and is a Certified Quality Auditor (ASQC).
Dr. Schiff has held major management positions in several of the leading health care and consumer products companies. His responsibilities, both domestic and international in scope include:
- WARNER-LAMBERT COMPANY
Group Vice President
Diagnostics Research and Development
- RESEARCH AND DEVELOPMENT COUNCIL OF NJ
Vice Chairman, Board of Directors
- HOFFMANN-LAROCHE, INC.
Director
Department of Diagnostic Research and Product
Development
- J.T. BAKER CHEMICAL COMPANY
(Richardson-Vicks)
Director of Research and Development
Diagnostics Division
- HYLAND DIVISION TRAVENOL LABORTORIES
(Baxter)
Manager
Serology Research
- TUFTS UNIVERSITY SCHOOL OF MEDICINE
Assistant Professor
Department of Anatomy
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