SuperlativeBio       "We Provide Superlative Biosciences Services." Superlative BioSciences Corporation 4734 Sabre Lane Manlius, New York 13104 Please call us at (315) 383-3496 or email info@superlativebio.com Services Provided by Superlative Biosciences Corporation ♦ Superlative Biosciences Corporation Provides Consultation On: The Preparation of Quality Manuals & Other Quality Documents including Change Control, Deviations, CAPA, FMEA, Trending, and Complaint Handling Biologics, Pharmaceuticals, Medical Devices, Cell & Tissue Therapy, Stem Cells, and Combination Devices Regulatory Guidance FDA/GLP, FDA/GTP, FDA/QSR, FDA/GMP, ICH, & ISO 9001 Documents Management. Preparation of SOPS, Master Batch Records (MBRs), CMC and Validation FDA Filings (CBER or CDER) & Inspections ♦ Other Business Services Provided Are: Technology Evaluation Market Reports Preparation of Business Plans Preparation of Marketing Plans Preparation of Biotechnology & Biomedical Articles and Online Study Guides ♦ We Also Prepare All Small Business Grants Whether Paper-Based or Web-Based/Electronic Submissions: SBIR and STTR Awards to the United States NIH, NSF, FDA, CDC, EPA, DOD, DOT and DHS Renewable Energy Grants Preparation and Writing Preparation of Supplies or Services Contract Proposals to All Agencies Grant Writing to US and International Private Foundations   SBIR and STTR Grants Information SBIR (Small Business Innovation Research) is a federal government program administered by 12 federal agencies for the purpose of helping to provide early-stage Research and Development funding to small technology companies. Solicitations are released periodically from each of the agencies and present technical topics of R&D which the agency is interested in funding. Companies are invited to compete for funding by submitting proposals that address the technical topic needs of the agency's solicitation. Each of these 12 agencies have various needs and flavors. To learn more about the needs of a particular agency, click on the links in the table below. STTR (Small Business Technology Transfer) is a smaller scale federal government program similar to SBIR. This program is administered by only 6 federal agencies. The major difference between the SBIR and STTR is that for the STTR the small business is required to work with a not-for-profit research institution or national laboratory on the proposed project. Superlative Biosciences Corporation can assist companies in applying for the SBIR & STTR programs. We can help you identify which agency or agencies will be interested in your technology, assist with writing and reviewing the proposal. If you need additional information or have any questions or comments, please use the contact form below.     Example Quality Management Case Study Corrective and Preventive Action (CAPA) Presentation Created by Superlative BioSciences Corporation FDA Links: 2010 Tentative FDA Advisory Committee Calendar - All FDA Centers Clinical Trials Information Drug Approvals at FDA Medical Device Approvals and Clearances at FDA FDA Press Releases and Announcements FDA Warning Letters Guidance Documents for FDA-Regulated Products Index to Drug Specific Information Medwatch Safety Alerts   Recommended eBooks Biotechnology and Biopharmaceuticals Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies. The Regulatory Challenge of Biotechnology Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book’s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency. Use the Coupon Code "Categorysalecp" on Ebooks.com to Get 20% Off the Price On the Ebooks Listed Above or Any Ebooks in the Categories of Education, Science Fiction, Study Aids, Technology and Transportation. Recommended Printed Books Sponsoring Products and Services Build a Web site yourself! It's a Snap, with easy to use instructions and templates provided by Network Solutions that you can customize to meet your needs. Thank you for visiting Superlative BioSciences Corporation Please contact us at (315)-383-3496 or info@superlativebio.com   © Copyright 2008-2010 Superlative BioSciences Corporation. All Rights Reserved.