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)|
|Azzur Labs, LLC|
|Biopharmaceuticals Consulting Group|
|Commissioning Agents, Inc.|
|Complya Consulting Group, LLC|
|DS InPharmatics LLC|
|GATEWAY ANALYTICAL, LLC|
|LABORATORY VALIDATION SPECIALISTS INC|
|Lachman Consultant Services, Inc.|
|MCGee Pharma International|
|Microbiology Consultants, LLC|
|PJC Pharma Consulting, LTD|
|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.
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.
Provides expert consultation for Pharmaceutical, Biotechnology, Biologics and Device industries. Services include:
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 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.
P.O. Box 34320
Indianapolis, IN 46234
Tel: +1 (317) 271-2550
Fax: +1 (317) 271-6097
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.
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!
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.
290 Concord Road
Billerica, MA 01821
Tel: +1 (800) 225-3384
Fax: +1 (978) 715-1393
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.
5316 William Flynn Highway
Gibsonia, PA 15044
Tel: +1 (724) 443-1900
Fax: +1 (866) 658-1445
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.
We provide quality, reliable consultation for Pharmaceutical, Biotechnology, Biologics and Device industries.
Our Services include:
Lachman Consultants provides expert technical/regulatory consultation in global activities for the Pharmaceutical, Biotechnology, Biologics, Device, Diagnostic, Dietary Supplements and Allied Health Industries.
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:
Microbiology Consultants, LLC focuses on providing expert microbiology consulting, contamination control, compliance, and training solutions for the pharmaceutical, biotech, medical device and other healthcare regulated industries. Dr. Michael J. Miller is our principal consultant who has practical experience in a wide range of pharmaceutical microbiology applications. With more than 25 years of hands-on industrial experience and almost 30 years of microbiology knowledge, you can be confident that you are working with one of the industry's most recognized and qualified pharmaceutical microbiologists.
We want to completely understand what your needs are in order for us to recommend an appropriate microbiology consulting program that will exceed your expectations. For a no-cost initial consultation, please telephone Dr. Michael J. Miller or email him directly at firstname.lastname@example.org.
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?
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 email@example.com. Please mention you heard about us on the PDA Directory.
17A Cleves Road
Suffolk, United Kingdom
Tel: +1 (44) 7774-841319
PJC Pharma Consulting Ltd.
Paul J Cummings - An Independent Pharmaceutical Consultant specialising in parenteral development and troubleshooting. The areas I can assist in include, but are not limited to, sterile product development plan reviews, strategy assessments, due diligence activities, specialist auditing of parenteral facilities to cGMP worldwide, troubleshooting activities relating to parenteral products, design of parenteral manufacturing facilities, ADME study design and implementation and general parenteral training.
Substantial experience of developing many different types of parenterals including aqueous-solutions, non- aqueous solutions, lyophiles, and syringe prefills. Work has encompassed initial development activities, scale up and technical transfer into factory networks worldwide. I am a former lecturer in parenteral development at two UK Universities and have extensive experience of design and qualification of a sterile development/production unit, including where required forming and initiating corrective actions for older facilities. Available to travel worldwide.
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.
700 Corporate Center Drive, Suite 201
Pomona, CA 91768
Tel: +1 (909) 784-3350
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: