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 Supplier and Services Directory please click on the insertion order form under downloads.
For more information please contact:
Vice President, Sales
Tel: +1 (240) 688-4405
Fax: +1 (301) 986-0296
|Click on company name for more information|
|Aseptic Processing, Inc. (Part of Veltek)|
|Associates of Cape Cod, Inc.|
|CyberVal Pharma, Inc.|
|ICQ Consultants Corp, “Engineering Better Solutions”|
|Lachman Consultant Services, Inc.|
|Lyophilization Technology, Inc.|
|ProPharma Group, Inc.|
Contact: Art Vellutato, Jr., VP Technical Support
Asseptic Processing, 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; Asepti-Cleanse sterile IPA/hand sanitizer hands-free dispensers; Environmental Monitoring Systems; Core2Clean Spray/Mop/Fog Systems.
124 Bernard E. Saint Jean Drive
E. Falmouth, MA 02536
Tel: +1 (888) 395-2221
Associates of Cape Cod, Inc. (ACC), is one of the world's largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1→3)-β-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products and medical devices. Our goal is to provide the best products and services, as well as the best technical support and customer service, in our industry to enhance the productivity and efficiency of all our customers. We are ISO 13485: 2003 certified, our laboratories are FDA Inspected and DEA Licensed and our Beacon Diagnostics ® laboratory is CLIA certified.
Our corporate headquarters are located in East Falmouth, Massachusetts with offices in the UK and Germany. Founded in 1974 by Dr. Stanley Watson, our company was the first to be licensed by the FDA to manufacture LAL for use as a quality control test for endotoxin detection in the pharmaceutical and medical device markets.
Bacterial Endotoxin Testing (BET) Workshop
We offer training courses on all aspects of endotoxin testing. Courses are conducted at our facility on Cape Cod or if you prefer we will customize a training course specific to your needs which can be conducted on site at your facility. We offer background and in-depth courses, as well as hands-on laboratory experience.
LAL Methodology and Background Topics include:
Contract Test Service (CTS)
Associates of Cape Cod,® Inc. Contract Test Service (CTS) laboratory specializes in testing for endotoxin and glucan contamination and has the most extensive experience of any endotoxin testing laboratory in the world. CTS performs all methods of the LAL assay: gel-clot, chromogenic, and turbidimetric.
CTS is GMP compliant and ISO registered. CTS is licensed by the DEA as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with FDA, USP, EP and/or JP, depending on the specifications of the client.
In addition to routine testing, CTS has extensive expertise and the ability to:
CyberVal provides quality consulting and compliance services for the following:
Compliant Applications / Systems upgrades and new implementations for the Pharmaceutical, Medical Device, and Biopharma – Laboratory and Manufacturing:
ICQ Consultants Corp, “Engineering Better Solutions”
23 Frances Barber Drive
Hope Valley, RI 02832
Tel: +1 (401) 440-2991
Fax: +1 (401) 633-6775
ICQ was established in 2007 and is currently headquartered in Hope Valley, RI. Integrated Commissioning & Qualification, Corporation supplies professionals to clients in the life science industry. Our services range from providing technical commissioning and qualification engineers to providing exceptional project management services and quality assurance support while focusing on the interest of our clients and the industry.
We concentrate on executing commissioning and qualification activities, as well as development and continuous improvements in the area of quality systems.
In short ICQ has established a reputation for engineering better solutions by providing services directly to our clients or by helping to bring people together. This will provide support to our clients and industry that will eliminate redundancy of verification, and develop programs that maximize the effectiveness and efficiency from start up throughout the life cycle of a facility.
Lachman Consultants provides expert technical/regulatory consultation in global activities for the Pharmaceutical, Biotechnology, Biologics, Device, Diagnostic, Dietary Supplements and Allied Health Industries.
30 Indian Drive
Ivyland, PA 18974
Tel: +1 (215) 396-8373
Fax: +1 (215) 396-8375
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.
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.
10975 Benson Drive, Suite 330
Overland Park, KS 66210
Tel: +1 (888) 242-0559
Fax: +1 (913) 663-2729
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.
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: