Accelrys

25 South Street
Hopkinton, MA 01748
Tel: +1 (508) 497-9911
Fax: +1 (508) 497-2396
Website: www.velquest.com

VelQuest's SmartLab™ GMP Lab Execution System, includes our new gmpLIMS Applications, ELN and Instrument Data System, replaces QC and production batch record paperwork with electronic data capture, rigorous method/SOP execution and instrument/equipment integration. See our new Microbiological Environment Monitoring application. The system reduces compliance risks by 10X, connects to existing IT/IS systems, reduces QC and Production cycle times by over 50% and labor costs by 20% compared to manual, paper processes.

Afton Scientific Corporation

2030 Avon Court
Charlottesville, VA 22902
Tel: +1 (434) 979-3737
Fax: +1 (434) 979-3738
Website: www.aftonscientific.com

Afton Scientific provides cGMP contract sterile filling services of investigative new drugs, biologics and commercial injectable pharmaceuticals. Afton also prepares and ships pre-packaged sterile empty vials (Ready-to-Fill®) to companies worldwide for immediate use in cGMP filling operations. Afton's customers include small biotechs, multinational pharmaceutical companies and major research institutions.

Agilent Technologies

2850 Centerville Road
Wilmington, DE 19808
Tel: +1 (302) 636 -1602
Website: www.agilent.com

Agilent Technologies Inc. (NYSE: A) is the world's premier measurement company and a technology leader in chemical analysis, life sciences, electronics and communications. Agilent is committed to providing innovative measurement solutions that enable scientists, researchers, and engineers address their toughest challenges with precision and confidence. With the help of our products and services, our customers and partners-- the leaders in their fields -- are better able to deliver breakthroughs that make a measurable difference. In more than 100 countries—wherever there's a need for measurement and testing—Agilent is at the forefront. No other company offers Agilent's breadth and depth of measurement tools and expertise across chemistry, biology and electronics.

Aptar Stelmi

600 Alexander Road
Princeton, NJ 08540
Tel: +1 (800) 452-9199
Fax: +1 (609) 452-7979
Website: www.aptarstelmi.com

Aptar Stelmi offers the highest quality specifications for RTS and RTU closures and syringe componentry. Our established ULTRACLEAN6 process offers the lowest particulate and endotoxin specification available; and our PREMIUM FILL process improvement reduces these already low limits, demonstrating the highest degree of control for CLEAN ROOM stopper preparation.

bioMèrieux Industry, Inc.

595 Anglum Rd.
Hazelwood, MO 63042
Tel: +1 (314) 731-8884
Fax: +1 (919) 620-7006
Website: www.biomerieux-usa.com

bioMérieux provides a broad range of solutions for the pharmaceutical industries in the fields of quality control, sterility control, water control and environmental control. In December of 2008, bioMérieux acquired PML Microbiologicals Inc., a leading provider of culture media and microbiological products.   In 2009 an innovative Media Fill test was launched, using vegetable peptones and a color indicator.

Commissioning Agents, Inc.

652 N. Girls School Road, Suite 240
Indianapolis, IN  46214
Tel: +1 (317) 271-2550
Fax: +1 (317) 271-6097
Website: www.commissioningagents.com

Commissioning Agents, Inc. provides compliance services for biotech, pharmaceutical, medical device manufacturers world-wide. These services include clinical and commercial products as well as API and excipient suppliers.  Expertise includes PAI readiness, supplier management and audits, establishing and auditing internal quality systems, preparation of regulatory submissions, and assistance with regulatory issues.

Complya Consulting Group

810 Memorial Drive, Suite 105
Cambridge, MA 02139
Tel: + 1 (617) 475-3470
Fax: + 1 (877) 308-8261
Website: www.complya.com

Every day, someone from Complya’s team of 40 QA and Regulatory Affairs consultants:

• Performs a supplier audit,
• Writes an SOP,
• Helps a client prepare for a PAI inspection,
• Performs a GMP Training,
• Helps to prepare an IND or NDA/BLA,
• Or provides a range of other GMP, GCP, and GLP services.

EAS Consulting Group

1700 Diagonal Road, Suite 750
Alexandria, VA 22314
Tel: +1 (571) 447-5500
Fax: +1 (703) 548-3270
Website: www.easconsultinggroup.com

EAS Consulting Group is a leading provider of regulatory consulting services to the pharmaceutical industry.  Staffed with former FDA officials and industry experts, EAS offers unparalleled expertise assisting clients in developing regulatory strategies, implementing quality assurance programs, filing regulatory submissions and ensuring compliance with FDA regulations.

Food & Drug Administration- Center for Drug Evaluation & Research

11400 Rockville Pike, Suite 601
Rockville, MD 20852
Tel: +1 (301) 827-2000
Fax: +1 (301) 827-3843
Website: www.fda.gov/cder

FDA's Center for Drug Evaluation and Research (CDER) will be exhibiting at PDA this year.  We will have information on CDER's mission at our booth, and will also provide any prospective employees with information on how to apply for open positions.  We hope you will stop by to see us! FDA is an Equal Opportunity Employer (EEO).

Genesis Packaging Technologies

400 Eagleview Blvd., Suite 100
Exton, PA 19341
Tel: +1 (610) 458-4903
Fax: +1 (610) 458-4939
Website: www.gen-techno.com

Genesis Packaging Technologies (formerly Genesis Machinery Products) is a leader in the science and technology of pharmaceutical packaging and services. With over 50 years of experience Genesis offers a wide array of solutions including Westcapper Vial Capping Machines, Leak Testing Equipment, Residual Seal Force Equipment, Container/Closure Design and Consultation Services, Contract Package Development, Packaging Line Services, along with OEM Parts and Equipment Maintenance.

Lives International Corporation

99 Pine Hill Road
Nashua, NH 03063
Tel: + 1 (603) 821-1898
Fax: + 1 (603) 821-1888
Website: www.lives-international.com

Lives International is a manufacturer of data loggers and wire based systems for thermal mapping and validation for pharmaceutical and biotech industry. Lives International's systems improve thermal validation and mapping using easy-to-use technology & software; cut-down validation time to 50% vs. standard systems and increase confidence.

Maas & Peither GMP-Publishing

1060 First Avenue, Suite 400
King of Prussia, PA 19406
Tel: +1 (610) 768-8028
Fax: +1 (610) 337-9548
Website: www.gmp-publishing.com

The GMP MANUAL consists of 6 binders and a CD-ROM. This compilation of worldwide expert knowledge and current GMP Regulations is the only one available on the market which combines cGMP expertise and current regulations together. It is created to keep professionals compliant with the ever-changing challenges in the pharmaceutical industry.

MASTERCONTROL, Inc.

6322 S. 3000 E., Suite 110
Salt Lake City, UT 84121
Tel: + 1 (801) 942-4000
Fax: + 1 (801) 942-7088
Website: www.mastercontrol.com

MasterControl software enables regulated companies to get their products to market faster while reducing costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the product lifecycle from conception to commercialization. Solutions include quality management, document management, audit management, training management, supplier management, submissions management, and more.

Nipro Glass Americas

1200 N. 10th Street
Millville, NJ 08332
Tel: +1 (856) 825-1400
Fax: +1 (856) 765-2039
Website: www.niproglass.com

Nipro Glass Americas has a great legacy of pharmaceutical glass manufacturing dating from the 19th century under the leadership of the Wheaton family. Nipro is a vertically integrated glass manufacturer operating globally from the US, Europe, India, China and Japan. We supply glass packing and services to the pharmaceutical industry.

Novatek International

4480 Cote de Liesse, Suite 355
Montréal, Québec H4N 2R1
Canada
Tel: +1 (514) 668-2835
Fax: +1 (514) 336-6537
Website: www.ntint.com

Novatek International is a provider of the Nova-LIMS suite; 21 CFR Part 11 compliant software quality solutions that cater to the pharmaceutical/biotech industry. Solutions offered: Environmental/utility Monitoring, Stability Studies, LIMS, Document Management/CAPA/Personnel Training/Audit, Inventory Management, Packaging Material, Proof-reading, Automation, Equipment Calibration and PM.

NSF-DBA, LLC

129 South St. 6th Floor
Boston, MA 02111
Tel: +1 (857) 277-0060
Fax: +1 (857) 284-7207
Website: www.nsf-dba.com

NSF-DBA has an outstanding reputation for cGMP consultancy, training and auditing in pharmaceutical quality management and regulatory compliance. NSF-DBA's services are first choice for major multinationals and small start-up ventures worldwide; providing training to professionals on regulatory compliance issues through GMP, Human Error and Qualified Person and Quality Professional classes.

PAREXEL International

195 West Street
Waltham, MA 02145
Phone: +1 (781) 487 9900
Fax: +1 (781) 768 5512
Website: www.parexel.com

PAREXEL International, a leading global biopharmaceutical services organization, has been a proven partner of pharmaceutical, biotechnology, and medical device companies for 30 years. Together with our customers, we have applied expertise, resources, and technologies in a shared mission to develop life-saving therapies for patients around the world.

ProPharma Group

10975 Benson Drive, Suite 330
Overland Park, KS 66210
Tel: + 1 (913) 661-1662
Fax: +1 (913) 663 2729
Website: www.propharmagroup.com

ProPharma Group is an industry leader providing validation, compliance, program/project management, medical information, automation, information technology, software development and technical services to the pharmaceutical, biotechnology, medical device and related industries.  Client speed to market, aggressive deadlines, and a challenging and changing regulatory environment are factors that experienced PPG personnel can assist your organization with in meeting and realizing its competitive advantage.

QUMAS

66 York Street
Jersey City, NJ 07302
Tel: + 1 (973) 805-8600
Fax: + 1 (973) 377-8687
Website: www.qumas.com

QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 260 global customer deployments and domain expertise in regulatory compliance since 1994. The QUMAS Compliance Platform is available on Microsoft SharePoint 2010, Oracle, EMC Documentum and Microsoft SQL Server.

Regulatory Compliance Associates

7401 104th Avenue, Suite 160
Kenosha, WI 53142
Tel: + 1 (262) 842-1250
Fax: + 1 (262)842-1251
Website: www.rcainc.om

In the pharmaceutical, biotech, and medical device industries, Regulatory Compliance Associates Inc. brings full-spectrum solutions to compliance, regulatory and operational challenges.  We offer top-tier strategic planning, mid-level project management, and hands-on support to provide a customized plan of action to meet our clients’ needs.

SCHOTT North America, Inc. –Pharmaceutical Packaging

30 Lebanon Valley Parkway
Lebanon, PA 17042
Tel: +1 (717) 228-4200
Website: www.us.schott.com/pharmaceutical_systems

SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic, analytical, dental & ophthalmic markets. Products include glass and polymer prefillable syringes (bulk and sterile), cartridges, ampoules, vials, and innovative coated containers (SCHOTT Type I plus®, TopLyo™, PURGARD®).

Sparta Systems, Inc.

2137 Hwy. 35
Holmdel, NJ 07733
Tel: +1 (732) 203-0400
Fax: +1 (732) 203-0375
Website: www.spartasystems.com

Sparta Systems’ enterprise quality management solutions enable high-value organizations to safely and efficiently deliver products and services to market. Our TrackWise software is used by quality, compliance and regulatory professionals to reduce risk and improve safety. Since 1994 we have been delivering a complete technology platform that manages quality-related risk across the enterprise and critical supplier networks.

Veltek Associates, Inc.

15 Lee Blvd.
Malvern, PA  19355
Tel: +1 (610) 644-8335
Fax: +1 (610) 644-8336
Website: www.sterile.com

Veltek Associates, Inc. is an EPA and FDA registered manufacturing facility.  We focus on identification and control of contamination in classified areas.  We produce a complete range of sterile pharmaceutical grade disinfectants, sporicides, lubricants, and buffer solutions; Aseptic-Cleanse sterile IPA and hand sanitizer, hands-free dispensers; Environmental Monitoring Systems; Core2Clean Spray/Mop/Fog Systems.

Waters Corporation

34 Maple Street
Milford, MA 01757
Tel: +1 (508) 478-2000
Fax: +1 (508) 872-1990
Website: www.waters.com

Waters Corporation creates business advantages for laboratory-dependent pharmaceutical organizations by delivering scientific innovation to enable customers to make significant advancements. Waters helps customers make profound discoveries, optimize laboratory operations, deliver product performance, and ensure regulatory compliance with a connected portfolio of separations and analytical science, laboratory informatics, mass spectrometry, as well as thermal analysis.

West Pharmaceutical Services, Inc.

530 Herman O. West Drive
Exton, PA 19341
Tel: +1 (610) 594-2900
Fax: +1 (610) 594-3000
Website: www.westpharma.com

West works side-by-side with healthcare partners from concept to patient, designing and manufacturing packaging, diagnostic and delivery systems that promote efficiency, reliability and safety. West leads the way with cutting-edge technologies and quality systems, a thorough understanding of regulatory compliance, and an unmatched knowledge of pharmaceutical product testing, development and packaging.

Accelrys 

25 South Street
Hopkinton, MA 01748
Tel: +1 (508) 497-9911          
Fax: +1 (508) 497-2396
Website: www.velquest.com

VelQuest's SmartLab™ GMP Lab Execution System, includes our new gmpLIMS Applications, ELN and Instrument Data System, replaces QC and production batch record paperwork with electronic data capture, rigorous method/SOP execution and instrument/equipment integration.  See our new Microbiological Environment Monitoring application.  The system reduces compliance risks by 10X, connects to existing IT/IS systems, reduces QC and Production cycle times by over 50% and labor costs by 20% compared to manual, paper processes.