Celsis Rapid Detection

600 W Chicago Avenue, Suite 625
Chicago, IL 60654
Tel: +1 (312) 476-1200
Fax: +1 (312) 476-1291
Website: www.celsis.com/rapid

Release safe products to maket faster with Celsis Rapid Detection systems. Exclusive use of adenylate kinase (AK) amplifies a viable signal: release in 24 hours for Limits testing; less than half the time of traditional Sterility testing. Free financial impact report helps you prove the value. Celsis.com/pharma http://Celsis.com/pharma

ComplianceLogix

PO Box 276
Boxford, MA  USA
Tel: +1 (617) 575-9259
E-mail:  info@compliancelogix.com
Website:  www.compliancelogix.com
COMPLIANCELOGIX provides effective training and consulting services for the biopharmaceutical industry. 

TRAINING ON-DEMAND
Relevant training topics designed to help you meet regulatory requirements.  Our online GMP, GCP and GLP compliance training courses include an audio-video presentation and competency assessment.  A printable course certificate is available upon successful completion of each course.  Enjoy the benefits of a secure, real-time multimedia learning experience with no travel required.  The resources you need are already at your fingertips – all you need is an internet connection.  Learn information critical to your business needs, when you need it.

CONSULTING
Our industry experienced professionals provide compliance consulting services including GMP, GCP and GLP vendor audits, clinical investigator audits, batch record review, quality systems design and implementation, creation of Standard Operating Procedures, and review of study documents.  We offer complete audit management services and can establish virtual Quality Assurance departments to meet the needs of your organization.

Contact us at info@compliancelogix.com to discuss how we can help you to effectively meet your compliance goals.

Design Space Inpharmatics

P.O. Box 263
Sumneytown, PA 180084
Tel: +1 (215) 272-4275
Fax: +1 (800) 934-5757
Email: jseibert@dsinpharmatics.com
Website: www.dsinpharmatics.com

DSI, a full service CMC Regulatory and operations consulting firm, combines in-depth technical knowledge of product development with regulatory strategy and content authoring for all phases of the review and approval process in the U.S., Canada and Europe. DSI's team approach integrates regulatory affairs with CMC experts specialized in API, formulation, process development, analytical chemistry/QC, fill/finish, cGMP audits, QA/compliance and experienced with a wide range of dosage forms of small molecules, peptides, and biologicals.

Our CMC Regulatory consultants have longstanding relationships with the FDA (CBER and CDER), EMEA and EU country regulatory authorities. We author regulatory content for investigational drug submissions and marketing applications (CTD/eCTD), Drug Master Files, annual reports, information packages and design strategies to address difficult technical issues with regulatory authorities. Not just advice. DSI provides you with flexible resources and expanded operational capability to design and implement a compliant and efficient product development strategies and timelines.

IMA Life North America, Inc.

2175 Military Road
Tonawanda, NY 14150
Tel: +1 (716) 695-6354
Fax; +1 (716) 695-6367
Website: http://www.ima.it/

A global supplier of automated processing equipment for vials, ampoules and syringes. Equipment range includes rotary and linear washers, depyrogenation tunnels, liquid and powder fillers, freeze-dryers, loading/unloading systems, cappers and labelers. We provide solutions for laboratory, pilot and commercial processing needs.

Lachman Consultant Services, Inc.

1600 Stewart Avenue, Suite 604
Westbury, NY 11590
Tel: +1 (516) 222-6222
Email: LCS@LachmanConsultants.com
Website: http://www.lachmanconsultants.com

Lachman Consultants provides expert technical/regulatory consultation in global activities for the Pharmaceutical, Biotechnology, Biologics, Device, Diagnostic, Dietary Supplements and Allied Health Industries.

• Global Regulatory Services
• Global Submissions
• Regulatory Strategy
• Petitions
• Labeling
• Audits
• Compliance, Technical/Business Assistance, Opinions
• OIG, DHHS, FDA Negotiations
• Due Diligence, Product/Company Acquisitions
• Expert Witness/Subject Matter Expertise
• Start-Ups/Virtual Companies Policies/SOPs
• Regulatory Findings/Consent Decrees Remediation
• Quality Systems/Control Programs
• Policies, Standards, Procedures
• Quality Manual Development
• Laboratory Control Systems/Design Specifications
• Validation/Qualification
• Computer Systems
• Sterile/Non-Sterile, API Manufacture
• Sterilization, Lyophilization, Sanitization Systems
• Master Validation Plans
• Supply Chain Management
• Warehousing/Distribution
• Enterprise Systems
• E-Pedigree Support
• Technical Assistance
• Stability Testing/Expiration Dating
• Dosage Form Design
• API Process Development
• BA/BE
• QbD/PAT
• Training
• Regulatory Training
• GMP Corporate Governance
• OJT
• Training the Trainer/Supervisor
• Risk Management

LexaMed, Ltd.

705 Front Street                
Toledo, OH  43605
Tel: +1 (419) 693-5307
Fax: + 1 (419) 691-0408
Email: info@lexamed.net  
Website:  www.lexamed.net

LexaMed offers consulting and laboratory services to pharmaceutical and biologics manufacturers.  Our team consists of individuals with many decades of industrial experience over a wide range of specializations.  We can assist in projects from a simple audit to the management and staffing to bring a product to market to a comprehensive corrective action response to a Warning Letter or Consent Decree.  We offer training programs in microbiology, sterilization, investigations and CAPA, environmental monitoring, aseptic processing, Quality Systems, validation, and management.
 
Areas of Specialization: Audits/Inspections; Biological Indicator Certification; Disinfect Efficacy Studies in Pharmaceutical Matrices; D-value Determinations; Environmental Isolate Resistance Studies; ISO 13485 Certified Laboratory; Isolator and Equipment Validation; Microbiological Research and Support Studies; Packaging Validation/Closure Integrity; Process Validation; Project Management; Quality Systems/GMP; Sterilization Validation, Process Design; Training.

Lonza

8830 Biggs Ford Road
Walkersville, MD 21793, USA
Tel: +1 301 898 7025, 800 638 8174 (toll free)
Fax:+1 301 845 8291
E-mail: scientific.support@lonza.com, scientific.support.eu@lonza.com
Website: www.lonza.com

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. Lonza’s QC Testing Solutions supports the critical needs of QC laboratories by supplying endotoxin detection reagents, equipment, consumables, and WinKQCL™ Endotoxin Detection and Analysis Software.

Lonza also offers rapid microbiology products that are reliable, easy-to-use, and provide same-day results for many quality control applications. The MycoTOOL® PCR Mycoplasma Detection Kit from Roche is now available through Lonza. Approved by the European Medicines Agency (EMA), the MycoTOOL® PCR test is the first commercially available assay to replace traditional, time-consuming mycoplasma culture tests for release testing of several pharmaceutical products.

Our Endotoxin and Mycoplasma Testing Services have been established to provide customers the option of outsourcing their testing.  Our Testing Services combine Lonza’s expertise with full service reporting, offering both research and pharmaceutical customers routine and customized testing.

For additional information, visit www.lonza.com.

Lyophilization Technology, Inc.

30 Indian Drive
Ivyland, PA 18974
Tel: +1 (215) 396-8373
Fax: +1 (215) 396-8375
Website: www.lyotechnology.com

Lyophilization technology, Inc. is a contract Development and Manufacturing Organization providing development services and technical support focused on lyophilized products. Experience with a wide variety of products including small molecules, cytotoxics, biologics, highly potent compounds, vaccines, medical devices, and diagnostic agents, LTI has provided services and support spanning start-up, virtual and multinational companies. A comprehensive range of services consists of thermal analysis, formulation development, process engineering, design space studies, clinical supplies manufacturing for freeze dried pharmaceuticals, biologics, diagnostics, biopharmaceuticals and fine chemicals. Technical support encompasses consultation on equipment specifications, technology transfer, validation, product and process validation, troubleshooting, streamlining operations, compliance auditing and training. 

When your needs are lyophilization, our focus is on your product...
Please visit our website or call us to discuss your project needs.

Microbiology Network, Inc.

150 Parkway
N. Chili, NY  14514
Tel: +1 (585) 594-8273
E-mail: scott.sutton@microbiol.org  
Website: http://www.microbiol.org
@MicrobiologyNet

The Microbiology Network a network of expert Quality consultants – all subject matter experts – for consultation, microbiology quality assurance training, and expert witness services to CGMP pharmaceutical, medical device, and over-the-counter companies around the globe.  The focus is on addressing your problems while working within your system and corporate culture to design practical systems.  All consultants have decades of experience in regulatory, QC or laboratory leadership roles.  We apply proven, practical solutions to training and consulting engagements. Solutions are based on a balance of good science, client needs, current international industry standards.

Our consultants are ready to assist with training or consultation services:

• Contamination Control strategies/analysis
• Analysis of Objectionable Organisms
• Investigations of Microbiological Data Deviations (MDD)
• Sterility assurance and aseptic processing
• Environmental monitoring – design & qualification of program, trending of data, continued compliance
• Microbiology lab design, data review, audits, optimization and management
• Product support (“virtual” microbiology lab)
• cGMP compliance
• Lab SOP structure and system design
• Pharmaceutical, OTC, biologics, cosmetic, contact lens care and ophthalmic formulation product development, QC testing
• Pharma, Medical Device, Biologics and Personal Products GMP
• Bacterial Endotoxin Test issues
• Rapid Microbiological Methods (RMM)
• Regulatory audit preparation and response (Mock FDA audits, assistance with 483/Warning Letter responses)
• Expert In-house (or distance) training

Put our network of GMP and contamination control experts to work on your consulting or training needs.  Contact us at +1(585) 594-8273 or at info@microbiol.org.

NSF-DBA LLC

101 Federal Stree, Suite 19
Boston, MA 02110
Tel: +1 (617) 342-3625
Fax: +1 (617) 342-3623
Email: USinfo@nsf-dba.com
Website: www.nsf-dba.com

NSF-DBA Pharmaceutical Training, Consultancy and Auditing Experts

Since 1986, NSF-DBA, formerly David Begg Associates, has been one of the leading providers of pharmaceutical training globally with an outstanding reputation for comprehensive training, pharmaceutical quality management and regulatory compliance. Since 2008, NSF-DBA has been offering extensive courses throughout the USA from its North American base in Boston, MA.

NSF-DBA services are the first choice of major multinationals and small start-up ventures and all are given with one aim in mind: to educate your pharmaceutical staff to the highest standards and offer the best possible advice to contribute to your company's success.

Quality Leadership Program - Since October 2009, NSF-DBA has been offering a series of modular training to Quality Professionals in the US.  Based on our highly successful Qualified Person training, delegates enrolling for the Quality Leadership Program will be able to register for a postgraduate diploma or Masters degree in Pharmaceutical Quality Management and GMP from the University of Strathclyde, a leading technical university in the UK.

Regulatory Compliance Associates, Inc.

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

Regulatory Compliance Associates Inc. (RCA) is a committed team of top tier consulting professionals with years of deep experience in FDA-regulated industries. We enjoy long-term relationships and share many notable successes with our clients, both large and small, across the world. RCA is a leading provider of compliance and operational services to the pharmaceutical industry. We know how to get things done – on time and on budget.

Below is a partial list of services we bring to the Pharmaceutical Industry:

• Quality Systems Development & Remediation
• Compliance Strategy
• Inspection Readiness
• Global Regulatory Strategies, Submissions & Registrations
• Response Strategy and Remediation Support for Regulatory Observations, Warning Letters, Consent Decrees
• Validation/Qualification Strategy and Execution
• Project Management
• Risk Management
• Quality/Supplier Audits & Inspection Readiness
• M&A and Integration
• Technical and Operational Due Diligence
• System Consolidation
• Facilities
• Remediation
• Compliance, Technical/Business Assistance, Opinions
• Training
• Computer Systems Validation
• Sterilization Cycle Development and Validation
• Enterprise Systems validation
• Stability Program Support
• Expert Witness
• Outsourced RA/QA functions
• Policies, Standards, Procedures
• Laboratory Control Systems/Design Specifications
• GMP Corporate Governance

Contact our Leadership Team for more information:

Mitch Januszewski – m.januszewski@rcainc.com
Mike Parkes, COO – m.parkes@rcainc.com
Mike Silvola, Program Director – m.silvola@rcainc.com

Tunnell Consulting, Inc.

900 E. 8th Avenue, Suite 106
King of Prussia, PA 19406
Tel: +1 (610) 337-0820
Fax: +1 (610) 337-1884
Website: www.tunnellconsulting.com 


With a strong focus on the life sciences industry, Tunnell Consulting designs and implements sustainable solutions that improve the operating performance of each unique client we serve.  Integrating technical, process and organizational skills, our proven problem-solving methodologies enable life science companies to achieve optimal compliance and quality performance, operational excellence and organizational effectiveness.  Since our founding in 1962, our experienced professionals, representing a wide range of scientific, technical, analytical and business disciplines, have worked with leading life science companies to achieve increased efficiency and measurable results that show up on the top and bottom lines.   Our capabilities include: Cost Reduction, Operational Excellence, Business Transformation, Process Understanding, QbD, Technology Transfer, Quality and Regulatory Compliance and much more.  The greatest measure of our success continues to be the high percentage of clients who repeatedly return to us when they expand, reorganize or encounter an organizational obstacle.  Visit us at www.tunnellconsulting.com . 

ValSource, LLC

918 Horseshoe Pike
Downingtown, PA 19335
Tel: +1 (610) 269-2808
Fax: +1 (610) 269-4069
Website: www.valsource.com

ValSource is a validation service and consulting company. We specialize in the planning, execution, and remediation of validation and related services. Our clients develop, manufacture, test, and distribute pharmaceutical, medical device, and/or biotechnology products and require assistance in the qualification of equipment and facilities and the validation of processes.

ValSource was founded in 1995 in response to a need for quality validation services at reasonable costs. ValSource offers independent services and is able to apply a pragmatic approach, concentrating on execution and delivery of the services required by the client to qualify their critical equipment, facility, and process. Our streamlined approach and optimal organizational structure allows ValSource to offer diverse, high-quality services with value at a significant cost reduction.
ValSource as a company and the individuals employed by ValSource have extensive experience in the evaluation, qualification and validation of sterile product manufacturing, filling, and support systems and processes.

ValSource employs over 120 full-time employees directly involved in the planning and execution of validation services and projects. ValSource maintains a remarkably stable work force, with one of the lowest employee turnover rates in the industry, in a business where reliable resources are essential. ValSource has worked for over 100 clients, executed more than 500 projects, in 20 states, with a combined project value of over $150 million on projects with a total value in excess of $1 billion. A significant portion of our business is ongoing work with long standing clients.

ValSource has made a corporate commitment to maintaining quality and service to our clients. ValSource values its employees, its clients, and its outstanding reputation for service and quality. Commitment to these values ensures that ValSource and its employees will always be there when you need them to provide the service necessary for a successful project.