specialtyoperations.com
Pre-Clinical Support
http://www.specialtyoperations.com/animal.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. Outsourcing the development and management of an animal care program to SOS ensures you receive the support you need to work with animals safely and humanely while meeting your research goals. We can design, build and operate animal care programs for all species. We provide safety training on equipment and help you establish and efficiently operate a compliant Institutional Animal Care and Use Committee. Insufficient ...
specialtyoperations.com
Specialty Operations Solutions
http://www.specialtyoperations.com/index.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. Leading Supplier of CGMP and GTP. Superior and cost-effective solutions to help you meet your goals. SOS has comprehensive services for all facets of your operation. Compounded Sterile Preparations Services. We can help you achieve and maintain a compliant operations. If your pharmacy program dispenses compounded. Sterile preparations, your facility must. Be equipped to operate under the provisions. 95% of All Drugs.
specialtyoperations.com
CGMP/GTP/USP
http://www.specialtyoperations.com/USP.php
Regulated Manufacturing and Compounding. Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. Regulated Manufacturing and Compounding. The Specialty Operations Solutions (SOS) division of WorkingBuildings focuses on CGMP and GTP manufacturing facilities, and USP. Compounding facilities. SOS services a wide range of client interests to include organizations from the pharmaceutical, gene therapy, bioengineering, animal health and public health sectors. Read our white paper.
specialtyoperations.com
Regulatory Services
http://www.specialtyoperations.com/regulatory.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. The regulation and compliance process for new products is rigorous. From pre-clinical studies to IND / BLA / NDA filings, a thorough and high-quality regulatory strategy demands expertise. Our experts will create a customized plan for your company or organization that ensures you get and pay for exactly what you need. Regulatory Strategy Planning and Submissions. Clinical Trial Plan Development and Support. 95% of dru...
specialtyoperations.com
Fail Fast
http://www.specialtyoperations.com/failfast.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. There are four statistically significant factors in the failure of a drug or biologic:. Lack of efficacy observed in Phase 3 clinical trials. A huge percentage of the total cost of drug development is spent during Phase 3 clinical trials. Lack of differentiation when compared to other competing treatment options leading to lack of commercial success. Unanticipated safety issues encountered after approval and marketing.
specialtyoperations.com
Specialty Operations Solutions - Services
http://www.specialtyoperations.com/services.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. Services Provided By Specialty Operations Solutions. We provide more complete and cost-effective solutions to science and technology firms than any subject matter expert in the industry. Deferred Needs Assessment (DNA). Fail Fast. Read More →. We have senior in-house Subject Matter Experts available to develop a new private cord blood banking program for you, or work with you and FDA to complete and submit a Biologics...
specialtyoperations.com
Specialty Operations Solutions - News / Events
http://www.specialtyoperations.com/events.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. Manufacturing in your Compounding Pharmacy? Be in control of your compounding environment. Atlanta, Georgia, June 17, 2014 Simply stated, USP. US Senate backs bill to regulate bulk drug compounding. Specialty Operations Solutions joins The WorkingBuildings Companies. DHMRI Announces strategic partnership with Specialty Operations Solutions, Inc. (SOS) to provide Operations Management and Marketing Support. Warwick, RI...
specialtyoperations.com
Specialty Operations Solutions - Our Work
http://www.specialtyoperations.com/ourwork.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. This page is currently being updated. Please check back soon for more information. 1230 Peachtree Street N.E. Atlanta, GA 30309. Kapa'a, HI 96746. Sign up for our corporate newsletter to get quarterly updates and industry news. 2013 All Right Reserved.
specialtyoperations.com
Programming Management
http://www.specialtyoperations.com/management.php
Public and Private Cord Blood Banking. Cell Therapy and Regenerative Medicine Services. SOS provides the following Program Management services:. Work with your staff to craft a development plan for the product. Craft a complete QA system for your firm. Coordinate any research animal work that is required, including performing the work in facilities operated by SOS professionals. Develop an IND with you to move the product into the clinic. Develop and publish a compliance plan set for FDA. 95% of drugs th...
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