Parenteral Drug Association

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2009 Consultants Directory

Are you in need of pharmaceutical or biopharmaceutical consulting services to help your company reduce costs and improve your manufacturing capabilities?

For more information please contact:

Nahid Kiani
VP of Membership Services and Sales
Tel: (301) 656-5900 ext. 128
Fax: (301) 986-0296
Email: kiani@pda.org

Halleh Z. Sameni
Senior Sales Administrator
Tel: +1 (301) 656-5900 ext. 135
Fax: +1 (301) 986-0296
Email: sameni@pda.org


David Begg Associates (USA) LLC

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

David Begg Associates are specialists in providing top quality GMP consultancy, auditing and training to the pharmaceutical industry worldwide.

Consulting: DBA consultants are experienced industry professionals with broad based GMP experience. DBA consulting includes due diligence assessments, quality system assessments, pre-approval inspection preparation, facility design and validation and the DBA team will offer advice on most any GMP topic.

Auditing: DBA auditors have conducted hundreds of audits throughout the pharmaceutical supply chain covering API and excipient suppliers, contract manufacturers, contract laboratories, manufacturing and testing facilities and distribution facilities.

Training: DBA is widely regarded as a premier provider of pharmaceutical training and every year literally thousands of delegates from all over the world benefit from attending DBA’s courses. DBA has been training staff from the pharmaceutical industry in Europe since 1986 and in the US since 2004.

DBA’s Quality Leadership Program is core program which has been offered internally at leading companies such as Pfizer, Wyeth, Sanofi and Genentech and will be offered from Boston starting October, 2009.
Biopharmaceuticals Consulting Group

Biopharmaceuticals Consulting Group
P.O. Box 3235
Danville, CA 94526
Tel: (925) 648-4118
Email: fsaless@biopharmaceuticalsconsulting.com
Website: www.biopharmaceuticalsconsulting.com

Offers clients assistance to QA, QC and manufacturing with GMP compliance, regulatory submissions for US and Europe, and establishing quality systems. Services include BLA, IND and NDA submissions, pre- and post-approval inspections, smooth transfer from clinical to commercial operations; developing quality systems; change control; environmental monitoring system; investigations; deviations; laboratory systems; process characterizations; monitoring and PAT; Microbiology validation; auditing; vendor qualification system; corporate policies; documentation systems; post-approval changes; evaluation of organizations; material tracking system; risk management; complaints, pharmacovigiliance and drug safety; improving efficiency and compliance; in-house training; and many more customized projects.

EMD Chemicals, Inc.
EMD Chemicals, Inc.
480 S.Democrat Rd.
Gibbstown, NJ 08027 USA
Tel: (800) 222-0342
Fax: (856) 423-4389
E-mail: mogrady@emdchemicals.com
Web site: www.emdchemicals.com
Contact: Michael O'Grady

EMD is a leading manufacturer of laboratory and pharmaceutical production products. EMD’s broad line of products and services include custom API synthesis, high purity minerals, Parteck™ excipients and raw materials for parenteral formulations. EMD’s microbiology products include the MAS-100™ air samplers, Environmental Monitoring Software and irradiated TSB for media fills.
EnteGreat, Inc.
entegreat
1900 International Park Drive
Birmingham, AL 35243 USA
Tel: (205) 968-3050
Fax: (205) 968-3858
Email: marketing@entegreat.com
Website: www.entegreat.com

EnteGreat is a manufacturing consulting and systems integration company, serving primarily Fortune 500 manufacturing companies across North America. EnteGreat has a singular mission: to help manufacturing companies succeed. Our strategy focuses on combining the Management of Technology with Transformative Change to give global manufacturing companies the tools and the knowledge needed to bring about solid, substantial and sustained improvements.
Globepharm Consulting, Inc.
313 Pine Street
Deerfield, IL 60015
Tel: +1 (847) 914-0922
Fax: +1 (847) 914-0988
Email: manisfeld@globepharm.org
Website: www.globepharm.org

With over 400 clients in 27 countries, for 25 years we have had an unblemished track record of ensuring clients pass FDA inspections their first time through (no client who has listened to us has ever failed). To date 42 companies have succeeded (including API, sterile and non-sterile pharmaceutical manufacturers). Avail yourself of Globepharm’s expertise to ensure you pass an FDA inspection first time through.

We provide auditing and training services to any GMP standard (US-FDA, EU, Australia, Brazil, Canada, etc.); routinely perform supplier audits in China and India; assist clients recover from Warning Letters and Consent Decrees; provide facility design critiques and prepare qualification protocols and validation master plans; provide expert court testimony, and much more. If there is one thing we know, it is GMPs.
Lachman Consultant Services, Inc.
lachman

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
PAREXEL Consulting
PAREXEL Consulting
900 Chelmsford Street
Lowell, MA 01851
Tel: +1 (978) 848-2250
Fax: +1 (978) 848-2221
Email: Chris.lindgrea@parexel.com
Website: www.parexelconsulting.com

PAREXEL Consulting helps companies design and execute product development and commercialization strategies through a unique fusion of scientific, regulatory and business expertise.

We are the world’s largest dedicated life sciences consultancy focused on providing product development, regulatory affairs and GxP strategic compliance support to the biopharmaceutical and medical device/diagnostic industries. Our approach helps manage risk, ensure superior quality and drive performance for clients of all sizes, in all phases, worldwide.

PAREXEL Consulting has a global reach with over 300 staff worldwide.

Key Service Areas:
  • Early Stage Development
  • Clinical Trial Regulatory Services
  • Late Stage Development
  • GxP Compliance and Quality Systems
  • Due Diligence (Acquisitions, Partnerships, Licensing, Outsourcing)
  • Pricing and Reimbursement

Why PAREXEL Consulting?

Product Focused: We help maximize the potential of your products worldwide with a focus on regulatory compliance, safety and value.
Fusion of Expertise: We apply our unique fusion of scientific, regulatory and business expertise to every project, leveraged by our:

  • Global coverage
  • Full-spectrum services, therapeutic and technical breadth
  • Ability to align strategy and resources to maximize product potential
  • Strategy to operational execution capability
  • Trusted colleagues

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 978-848-2634 or ron.kraus@parexel.com. Please mention you heard about us on the PDA Directory.

Phoenix Regulatory Associates, Ltd.
21525 Ridgetop Circle, Suite 240
Sterling, VA 20166
Tel: +1 (703) 406-0906
Fax: +1 (703) 406-9513 
Website: www.phoenixrising.com
Email: phoenix@phoenixrising.com


Seasoned consultants. Ex-FDA-ers and industry experts who keep in touch with changes in policy, regulations and personnel at FDA. Located in the Washington DC area, we combine experience with a commitment to give each client consulting advice with maximum value. Phoenix has experience in the pharmaceutical, medical device, biologics, food ingredients, and dietary supplements industries. Our background is both scientific and technical so we can work with you to solve problems generated throughout the product life cycle -- from R&D, manufacturing, to marketing and distribution. Our client companies range from start-ups to multi-national corporations. Whether you want assistance with strategic regulatory planning, a premarket application, general compliance, clinical monitoring, GCP, IRB compliance, preparing for a PAI, audits, validation, implementing GMP/ISO 9000, or solving regulatory problems such as 483s and warning letters, Phoenix can help. We will give you the highest quality regulatory service!
Process Tek
1991 Big Bend Drive 
Des Plaines, IL 80016-3518 
Tel: (847) 296-9312 
Fax: (847) 296-9312 
Email: kaipurohit@processtek.net 
Website: www.processtek.net

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.
Raland Technologies LLC
Raland Logo
2275 Research Blvd, Suite 500
Rockville, MD 20850
Tel: +1 (877) 972-5263 x 825
Fax: +1 (866) 701-2455
Email: cmckenzie@raland.com
Website:  http://www.raland.com/

Raland Technologies, LLC provides research, design and consulting services to the Biotech, Pharmaceutical, and Medical Device Industries. Raland business sectors include: Life Science Solutions, Learning Solutions, Informatics, Controls and Automation Integration and Network Solutions.

Raland consults in FDA interactions, QS development and remediation. We offer a continuum of technical support services from engineering to validation planning and to execution. Raland associates are experienced with FDA/EMEA/MHRA/JP and know the risks and the techniques for successful implementation and improvements. Our regulatory services support global product development and commercialization. Our Learning Solutions create state of the art training modules including GDP, Adverse Event and Product Complaint Reporting and Product and Process which save our clients time, labor, and money.

Raland’s expert project management, technical prowess and regulatory expertise will culminate to deliver integrated solution efficiency with one point accountability for system design, factory testing, installation, start-up product development support and process validation.
Sterile and Liquids Consulting, LLC
102 Deer Run Court
Harleysville, Pa 19438 
Tel: +1 (215) 527-5761
Email: wah81750@comcast.net

To develop a new sterile or liquid product, you need to identify and complete a challenging set of tasks. Sterile and Liquids Consulting, LLC (SLC) has the expertise and over 30 years of experience to help you; and to help make your new sterile or liquid product a reality.

Why add SLC to the job?
  • SLC will bring an independent eye to your team and to your project. The SLC focus will be on the development issues and needs for your product and project. Helping you develop your product is SLC’s only job.
  • With experience based on the development of numerous commercial products, SLC knows the development job that needs to be done. SLC understands how to anticipate and resolve product development issues. SLC can help you deal with problems occurring over the entire development spectrum - from formulation design, clinical supply manufacturing, late stage development, scale up, technology transfer and putting your process into production.
  • SLC can provide expertise to help you assess technology and product opportunities for your new product or project - or to help you to investigate opportunities to fuel future growth in your organization.

Your decision to engage SLC to support the development of your sterile or liquid product or project is just smart business. Working with an expert in sterile products and liquids development is simply using the right tools to get the job done as efficiently as possible. Please contact SLC to get additional details regarding the expert services offered.

Validation Plus, Inc.
Validation Plus, Inc.

14 Penwood Road
Livingston, NJ 07039
Tel: +1 (866) 760-2483
Fax: +1 (973) 758-0220
Email: jeffreygasman@validationplusinc.com
Website: http://www.validationplusinc.com/

Validation Plus, Inc. (VPI) has been providing validation plus compliance consulting services to Pharmaceutical, Biotechnology, Medical Device and Tissue Banking firms since 1995. VPI will work with your organization to identify requirements and the best solutions to meet your expected outcomes.

Validation Plus focuses on helping build your successful project, and identifying and recommending solutions to your problems.

1. SATISFACTION

Validation Plus, Inc. is a company with one goal –Your Satisfaction. We have received letters of recommendation from our clients since 1996. Responding to our customers’ needs is the most important part of our business.

2. EXPERIENCE

Our Senior and Principal Consultants come from your industry; most have over ten years of experience. Our Principal Consultants have 20+ years of experience.

Each Validation Plus Senior and Principal Consultant has:

  • Hands on experience with multiple validation services and systems
  • Both education and practical experience in their field of validation
Working Words, Inc.
Working Words, Inc.

40 Lloyd Avenue, Suite 307A 
Malvern, PA 
Tel: +1 (610) 296-0274
Fax: +1 (610) 296-5469
Email: robm@workingwordsinc.com
Website: http://www.workingwords.com/

For nearly 20 years, we’ve been helping our pharmaceutical, biopharmaceutical and medical device clients sharpen critical thinking and technical writing skills, create clear, stand-alone documents and improve compliance and quality. We do this through cGMP consulting and training programs that are completely customized to our clients’ documents.

Our customized blended learning programs include:

  • Writing Effective Investigation Reports—including RCA and CAPA (English/Spanish version available)
  • Precision & Clarity in Technical Reports
  • Precision & Clarity in Regulatory Documents
  • Writing SOPs That Work
  • Root Cause Analysis and Writing for Operators (Spanish version available)

Our cGMP consulting services include:

  • Investigation System Remediation (overdue investigations, OOSs, forms, processes)
  • CAPA Effectiveness
  • Laboratory Systems and Procedures
  • Regulatory Documentation and CMC Auditing
  • Batch Sheet Revision
  • Validation and Change Control
  • GMP Auditing and GAP Analyses
  • Process Mapping and SOP Remediation
  • Documentation Coaching and Mentoring
Biologics Consulting Group, Inc.
1317 King Street
Alexandria, VA 22314
Tel: +1 (703) 739-5695
Fax: +1 (703) 548-7457
Email: jkenimer@bcg-usa.com
Website: www.bcg-usa.com
Eakins & Associates
Eakins & Associates
448 Dutch Neck Road
East Windsor, NJ 08520
Tel: +1 (609) 448 3411
Email: mneakins@comcast.net  
Contact: Dr. Michael N. Eakins

Eakins & Associates is dedicated to providing technical guidance and assistance to biotechnology and pharmaceutical companies in non-clinical drug development for parenteral products. We specialize in guiding companies in the selection of primary packaging for both glass and plastic containers and in development pharmaceutics from the pre-clinical stage through to development of the final formulation and product transfer into manufacturing operations.

• Primary Packaging:
- Product Development in Glass and Plastic Vials and Pre-filled Syringes
- Cyclic Olefin Plastics for Syringes and Vials
- Vendor Selection
- Extractables/Leachables
- Identification of CMOs
- Addition of authentication and track and trace technologies
- Compliance with International Regulatory Requirements
- Glass and Plastic Container Workshops

• Drug Development:
- Stability Protocols
- CMC Documentation Review
- Drug Master Files
Q Pharma, Inc.
Q Pharma Logo

22 South Street
Morristown, NJ 07960
Tel: +1 (973) 656-0011
Fax: +1 (973) 656-9101
Email: jessica.labita@qpharmacorp.com
Website:  http://www.qpharmacorp.com/

Q Pharma provides a complete suite of regulatory and quality solutions designed to make your business simple and successful. We pride ourselves on being a single-source solution provider, allowing you to manage your business with one partner and making your job easier. Founded in 1994, Q Pharma is a provider of the following solutions, delivered to the pharmaceutical, biotechnology, medical device and related industries:

• Validation Solutions
• PDMA Solutions
• Regulatory Compliance Solutions
• Direct Marketing Solutions
• Logistics Solutions
• Project Management Solutions
• Medical Device Solutions

At Q Pharma, we recognize that you have a choice in selecting a vendor for quality solutions. To that end, we work each and every day to offer the most comprehensive, effective and exceptional service possible.

Tom Bozzo Associates, Inc.

Tom Bozzo Associates, Inc.
1617 Guston Ct           
Silver Spring, MD 20906 
Tel: +1 (301) 871-1028
Fax: +1 (301) 871-9761
Email: tombozzo@comcast.net
Website: http://www.tombozzoassociates.com/

Tom Bozzo Associates, Inc. (TBA) is headed by the former Compliance Director of FDA (CBER) and provides consulting services to the Biologics, Pharmaceutical, Tissue, and Cellular product industries, specializing in compliance audits (Biotech, API, PAI, QA) and corrective action plans (483s, warning letters, license suspensions/revocations, recalls, etc.). FDA’s increased emphasis on GMP, GTP and systems compliance means that the regulated industry needs advice it can count on in identifying, preventing and correcting problems. TBA specializes in identifying underlying causes related to observations from internal/external audits or FDA inspection. FDA’s enforcement actions and product approval requirements make early resolution of regulatory issues imperative to any business’ survival. Tom Bozzo Associates offers experience with sterile products, solid dosage forms, blood products, therapeutics (biotech), vaccines, tissues and cellular products.
Vectech Pharmaceutical Consultants, Inc.
vectechlogo

Vectech Pharmaceutical Consultants, Inc. 
24543 Indoplex Circle 
Farmington Hills, MI 48335
Tel: +1 (248) 478-5820
Fax: +1 (248) 442-0060
Email: ajohnson@vectech.com
Website: http://www.vectech.com/

Vectech Pharmaceutical Consultants, Inc. offers comprehensive consultation and training programs to the pharmaceutical, biotechnology and medical device industries. We provide a full spectrum of services including Microbiology, Rapid Microbiology, Laboratory Issues, Contamination Control, Process Optimization, Design, Engineering, Integrated PAT Solutions™ ,Environmental Monitoring, Biostatistics, epedigree, and Regulatory Affairs. We believe that the most effective way to serve our clients is through a personalized approach, customized to precisely fit the needs of each client

With over 240 years of combined industry experience, our consultants can provide wisdom and turnkey services on time and within your budget. We specialize in providing comprehensive consulting and pride ourselves on bringing a regulatory, engineering and scientific perspective to every project. No matter what the job, Vectech will work with you and your staff to achieve the results you expect.
 
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