Are you in need of pharmaceutical or biopharmaceutical consulting services to help your company reduce costs and improve your manufacturing capabilities? To advertise in the PDA Consulting Services and Supplier Directory please click on the insertion order form under downloads.
For more information please contact:
David Hall Vice President, Sales Tel: +1 (240) 688-4405 Fax: +1 (301) 986-0296 E-mail: hall@pda.org
Aramark Cleanroom Services 115 N First St Burbank, CA 91502 800-ARAMARK www.aramarkuniform.com/cleanroom
Aramark Cleanroom Services is an industry leader in supplying validated sterile garments and contamination control supplies, serving critical environments in the pharmaceutical, medical device, microelectronics, semiconductor, and aerospace manufacturing industries.
Watch our video: www.aramarkuniform.com/campaign/cleanroom
15 Lee Blvd. Malvern, PA 19355 Tel: +1 (610) 644-8335 Fax: +1 (610) 644-8336 Email: artjr@sterile.com Website: www.sterile.com
Contact: Art Vellutato, Jr., President & CEO Aseptic Processing, Inc., an industry specific consulting service and Veltek Associates, Inc., an EPA and FDA registered manufacturing facility, work together to enhance the pharmaceutical, biotechnology, and medical device industry functioning. We focus on the identification and control of contamination in classified areas. API and VAI produce a comprehensive set of sterile pharmaceutical grade disinfectants, sporicides, cleaners, lubricants, waters, and detergents. Additionally, we offer, viable monitoring equipment, including our new SMA OneTouch ICS, cleaning equipment including our patented Core2Clean Plus System, laboratory services to evaluate disinfectant efficacy, and our new line cleanroom documentation systems that include paper, printers, and custom documentation. Together API and VAI are fully equipped to provide innovative processes and products that continually aim to improve cleanliness in any classified operation.
4125 Independence Drive Schnecksville, PA 18078 484.550.7709 Email: Carol.Julich@AzzurLabs.com website: www.AzzurLabs.com
Azzur Labs provides GMP/GLP compliant analytical services for the pharmaceutical, biotechnology, medical device, cell and tissue industries. We are registered with the PA Dept of Health, FDA and the DEA to perform analysis on Schedule II through Schedule V controlled substances.
Our main focus is to provide valid, accurate results with excellent customer service. We realize you have a choice when outsourcing your analytical testing and promise to go beyond your expectations to realize your outsourcing needs and assure your satisfaction.
Give us a call today to discuss your analytical needs.
P.O. Box 3235 Danville, CA 94526 Tel: (925) 648-4118 E-mail: fsaless@biopharmaceuticalsconsulting.com Website: www.biopharmaceuticalsconsulting.com
Provides expert consultation for Pharmaceutical, Biotechnology, Biologics and Device industries. Services include:
717 Indian Road Glenview, Illinois 60025 Tel: 1+ (630) 890-1259 Fax: 1+ (630) 510-0109 E-mail: ttredenick@biotechlogic.com Website: www.biotechlogic.com
BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical hands-on experience to assist clients in bringing their products to market quickly and successfully by augmenting and optimizing an organization's resources.
Our Value:
Our success is due to our ability to serve as the technical, manufacturing, quality and regulatory expert for consultation, or be the hands-on resource that drives and executes the plan.
810 Memorial Drive, Suite 105 Cambridge, MA 02139 Tel: + 1 (617) 475-3468 Fax: + 1 (877) 308-8261 E-mail: info@complya.com Website: www.complya.com
Every day, someone from Complya's team of 40 consultants:
Whether yours is a virtual company needing "ground up" Quality services, or an established pharma or biotech company simply needing an extra set of hands, we can help.
Complya is extremely careful about identifying the right QA consultant for your specific need. With our proprietary matching process, we can suggest the right person for your project, whether it be a seasoned ex-FDA industry expert or a talented mid-level Manager.
We look forward to hearing from you!
200 Spectrum Center Drive, Suite 220 Irvine, CA 92618 Tel: +1 (949) 336-5200 Website: www.enterey.com
Enterey brings operational excellence and project management best practices in order to drive value to initiatives focused on strategic, core and shared functions of the business in the areas of Capital Projects, Operations, and Quality.
When you partner with us, we help to deliver on your corporate objectives and we will exceed your expectations. Every project. Every time.
To learn more specific project details, visit www.enterey.com/our-project-briefs
For business development opportunities, contact (949) 336-5200
5316 William Flynn Highway Gibsonia, PA 15044 Tel: +1 (724) 443-1900 Fax: +1 (866) 658-1445 Website: www.gatewayanalytical.com
Gateway Analytical has a complete suite of analytical services to ensure that your drug product is of the highest quality and efficacy, from development to manufacturing.
Our characterization services are preformed in a cGMP- and ISO-compliant laboratory, providing particulate contamination and foreign particulate identification and source determination, particle sizing as well as consulting services related to 100% inspection process and non-conformance investigations.
In addition, we offer pharmaceutical forensic services that take an investigative approach to manufacturing and process issues, applying forensic expertise, analysis and problem solving principles to get to the root of deviation and out of specification investigations.
225 Yorkshire Drive Newtown, PA 18940 Tel +1 (267) 334-5722 Website: www.gmpscientific.com
GMP Scientific, Inc. is a global consulting firm organized to provide comprehensive services for FDA-regulated companies in the area of Quality System and Regulatory Compliance.
We provide cost effective and customized solutions to our clients in maintaining Sustainable Regulatory Compliance and a Robust Quality System thereby ensuring a healthy and viable enterprise.
Key Industry:
Pharmaceuticals, Medical Devices, Biotechnology, Aseptic and Sterile Operations. Why GMP Scientific?
Our Consultants are seasoned industry veterans with real life FDA experience that uniquely qualifies them to provide a high value service to you. We take great care in assigning the right person or team to the project. Our service model is cost-effective and value driven. Additionally, we support our projects with Strong Documentation Practices and professional management that are integral to the success of all FDA related projects. Key Services
Regulatory Compliance Program
Quality System Implementation
Process Improvement
Organizational Development
To discuss your needs please contact Vice President Archana Pandit at inquiry@gmpscientific.com. Call us @ 215-512-CGMP (2467) or visit us online at www.gmpscientific.com.
P. O. Box 3803 Lawrence, Kansas 66046 Phone: 1-785-218-4915 Email: cbrown@labvalspec.com Website: www.labvalspec.com
We provide quality, reliable consultation for Pharmaceutical, Biotechnology, Biologics and Device industries.
Our Services include:
Stafford House, Strand Road Portmarknock Co. Dublin, Ireland Tel: +353 (1) 8464742 Fax: +353 (1) 8464898 Email: info@mcgeepharma.com Website: www.mcgeepharma.com
McGee Pharma International, Pharmaceutical Quality & Training Specialists. Our panel of highly qualified consultants can work with you across all areas of GxP (GMP, GDP, GCP, GLP etc) including:
290 Concord Road Billerica, MA 01821 Tel: +1 (800) 225-3384 Fax: +1 (978) 715-1393 Website: http://www.emdmillipore.com/
EMD Millipore BioMonitoring is a top player in the field of industrial microbiology and process monitoring. This business field provides state-of-the-art testing methods, regulatory expertise and outstanding service to provide that one invaluable result: maintaining the safety of your products.
Focus markets include Pharmaceutical, BioPharma, Food andBeverage, Environmental and Cosmetics.
2001 Pennsylvania Avenue NW Suite 950 Washington, DC 20006 Phone: 202.822.1850 Web: www.nsfhealthsciences.org Email: uspharma@nsf.org
The Right People. The Right Solution. The First Time.™
Experts in pharmaceutical, biologics and biotech quality systems, compliance, regulatory affairs, auditing, education and training.
NSF Health Sciences Pharma Biotech Consulting provides international regulatory consulting services and training including FDA and EU expertise to support the development, manufacturing and marketing of pharmaceuticals, biologics, biotech biologics and combination products. Our core expertise is the design and implementation of successful efforts to resolve, or avoid, challenges posed in the development of new, innovative products. We work with a network of subject matter experts, across all therapeutic areas, to provide our clients with appropriate expertise in any field. We work to balance compliance with regulatory requirements with our clients’ business needs.
NSF Health Sciences Pharma Biotech provides these services:
NSF Health Sciences Pharma Biotech maintains a commitment to outstanding service and quality, and focuses on achieving the client’s business objectives through the use of sound science and expert experience. Our total product lifecycle approach allows us to provide our clients with the best solutions for their regulatory needs.
195 West Street Waltham, MA 02451 USA Phone: +1 (781) 487-9900 Fax: +1 (781) 768-5512 E-mail: chris.lindgren@parexel.com Website: www.parexel.com
PAREXEL Consulting provides integrated product development and commercialization consulting services, helping biopharmaceutical and medical device companies shorten time to market and maintain product viability for the long-term. Through our unique fusion of scientific, regulatory, and business expertise, we also help clients manage risk, and maximize product and portfolio value at every milestone and phase of development worldwide.
Key Service Areas:
Why PAREXEL Consulting?
Product Focused:
We help maximize the value of your products worldwide with a focus on efficient approvals, optimal market access, proactive compliance and safety. We apply our unique fusion of scientific, regulatory and business expertise to every project, leveraged by our:
We provide tailored solutions that fit your product, your needs, and your goals from individual ad hoc advice to full service strategic engagements, partial or full outsourcing, and executives on loan. Accountability, quality, and performance excellence is our trusted commitment to you.
To discuss your needs please contact Vice President Ron Kraus at ron.kraus@parexel.com. Please mention you heard about us on the PDA Directory.
1991 Big Bend Drive Des Plaines, IL 60016-3518 Tel: (847) 296-9312 Fax: (847) 296-9312 E-mail: kaipurohit@processtek.net Web site: www.processtek.net Contact: Kai Purohit
Kai received his PhD in 1972 from UMass in Food and Biological Process Engineering and has worked under the late Dr. C.R. Stumbo and Dr. M. Tung. Kai has also worked under Dr. I.J. Pflug's guidance. Kai's experience includes (12) years at General Foods and Baxter and industrial consulting for over the past (25) years.
Process Tek specializes in sterilization process engineering, R&D and validation services for optimal aseptic, thermal, chemical, irradiation and non-thermal processes. Kai has special expertise in Bio-Validation, Parametric Release, Process Isolators, HACCP and novel processes for sterile product and package manufacturing, including microwaves, pulse power and high pressure processes, and differential and selective processing. Kai provides technical assistance for validating seal integrity testers, sterilizing heat sensitive and labile products, verifying software and controls for Part 11 compliance, and offers HACCP and GMP audits and training services.
8717 W. 110th St., Suite 300 Overland Park, KS 66210 Tel: +1 (888) 242-0559 Fax: +1 (913) 663-2729 Website: www.propharmagroup.com
ProPharma Group is an industry leader serving the compliance needs of the pharmaceutical, biotechnology and medical device industries. The experts at ProPharma Group enable our customers to achieve continuous compliance and improve their operations in a complex and changing regulatory environment.
Our clients choose us because of our seasoned professionals, expertise, and the practical solutions we provide. They stay with us because we understand what it takes to deliver a project in-budget, on time, and in compliance.
We offer a wide array of services to meet our clients' many needs. Our services include:
Your trust means everything to us. Call our experts at 888-242-0559, or visit us at www.propharmagroup.com.
700 Corporate Center Drive, Suite 201 Pomona, CA 91768 Tel: +1 (909) 784-3350 Website: www.biotech.com
PSC Biotech’s expert life science consultants provide GXP audit, engineering and an array of validation services. PSC Clinical offers clinical trial data management, monitoring, auditing and training services. PSC Software has developed innovative applications that streamline the auditing process, organize your audits, and manage corrective and preventative actions.
SL Pharma Labs, Inc., a well-established GMP-compliant contract organization, specialized in parenteral and topical drug products, provides high quality customized services for drug product development and clinical manufacture (including both small and large molecules). Since 1997, SL Pharma Labs has provided high value formulation development, analytical development, microbiological development, early phase clinical manufacturing, commercial manufacturing support and quality control testing services for generic and innovator parenterals, liquids and topicals. SL Pharma has successfully completed several NDAs and ANDAs. Our mission is to support clients in meeting product development, analysis, regulatory and commercialization timelines.
What differentiates SL Pharma Labs from other CROs:
Eywiesenstrasse 5 Ravensburg, 88212 Germany Website: www.vetter-pharma.com
Vetter is a global leading contract development and manufacturing organization (CDMO) headquartered in Ravensburg with production facilities in Germany and the US. With years of experience and the dedication of our employees, we support companies from early process development through clinical and commercial filling to a wide variety of packaging solutions for vials, syringes and cartridges. Our customers represent the entire range of small to large companies in the pharmaceutical and biotechnological industries. As a provider of innovative solutions, we have made it our mission to work with our clients to develop injection systems for the continuous improvement of patient safety, comfort and compliance. We are committed to the principles of sustainability and act as a corporate citizen in a socially and ethically responsible manner. For more information, visit www.vetter-pharma.com.
Vetter Development Service
At Vetter Development Service, we partner with our clients from preclinical development through Phase III, featuring:
Vetter Commercial Manufacturing provides Phase III manufacturing through global market supply, featuring:
Vetter Packaging Solutions helps our clients match their product with the appropriate drug-delivery system (primary packaging); secondary packaging, and packaging services, featuring:
For US inquiries please contact +1-847-581-6888 or infoUS@vetter-pharma.com. For EU inquiries please contact +49-751-3700-0 or info@vetter-pharma.com. Visit www.vetter-pharma.com for more information.
PO Box 1300 Sturbridge, MA 01566 Tel: +1 (978) 851-0628 Fax: +1 (978) 824-2448 Website: www.wmprocess.com
White Mountain Process is a global supplier of high purity mixers, agitators, and mixing tank packages. Mixers include laboratory, to pilot plant, to production scale. The product line caters to biotech, pharma, diagnostics, and sanitary mixing and blending application. Stainless steel, exotic allows, and USP VI non metallic mix tanks are available. WMProcess excels at custom mixer design for complex application.