Aseptic Processing, Inc. (Part of Veltek)

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., 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, LLC

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.

• Water Testing and Validation
• Environmental Monitoring
• Microbial Limit Testing
• Bioburden Validation and Testing
• Bacterial Endotoxin Testing
• Compressed Air Testing and Analysis
• Cleaning Validations
• Bacteriostasis and Fungistasis
• Validation Services
• Certification Services
• Calibration / Maintenance Services

Give us a call today to discuss your analytical needs.

Biopharmaceuticals Consulting Group

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:

• Global regulatory compliance and submissions such as IND, BLA, NDA and post-approval changes
• Quality systems for QA, QC and manufacturing such as change control, environmental monitoring, validation system, stability program, investigations and CAPA, material tracking and supply chain management, auditing, training system, documentation, laboratory control systems, computerized systems
• GMP and GLP compliance, Pre- and post-approval inspections
• Smooth transfer from clinical to commercial operations, Process characterizations, QbD, PAT, Risk management
• Corporate policies, evaluation of organizations for efficiency and compliance, complaints, pharmacovigilance and drug safety
• Project management, in-house training; and many more customized projects

BioTechLogic, Inc.

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.

• Process Development: Development Reports, Design of Experiments (DOE), Technology Implementation, Transfer and Scale-up, Comparability, Troubleshooting, Technology and Facility Evaluations
• Manufacturing: On-Site Third Party Contract Manufacturing Support, Statistical Process Controls, Supply Assurance
• Process Validation: Strategy, Critical Process Parameter Evaluation, Validation Protocols and Reports, Support Validations (Resin Re-Use, Membrane Re-Use, Hold times, Loading Studies, etc.)
• Project Management: Project Plans and Schedules, Project Management, Team Organization, Meeting Management, Action Item Tracking, Budget Tracking
• BioAnalytical Services: Strategy, Hands-On, Expert Review, Analytical Method Transfer
• Quality Assurance: Audits, Mock PAI/PLI Audits, Global Pre-Approval Inspection Readiness and Remediation Programs, Quality Systems, On-Site Senior Management
• Regulatory Submissions: Briefing Packages, Agency Responses, IND's/IMPD's, BLA/MAA, 510K, PMA, PAS or ROW Filings
  Supply Chain Management: Site Selection, Make vs. Buy, Due Diligence
  Combination Products: Regulatory Strategy, Dossiers, CE Marking process

Our Value

• When you define a timeline, we will deliver services and proven quality documents within the given timeframes because we know that it means your company's success and future is on the line.
• We value our customers and personally take on the weight of their challenges as our own.
• We become a working, contributing team member who is able to support your manufacturing/development team, as well as management.
• We have a CMC focused staff. This means that when a problem arises we have experts to quickly resolve the issue.
• All of our personnel are full time employees. We are a trusted, high performing team that works to deliver your goals and be available when needed.

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.

Commissioning Agents, Inc.

P.O. Box 34320
Indianapolis, IN 46234
Tel: +1 (317) 271-2550
Fax: +1 (317) 271-6097
Website: www.commissioningagents.com

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.

Complya Consulting Group, LLC

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:

• Performs a supplier audit,
• Writes an SOP,
• Helps a client prepare for a PAI inspection,
• Performs a GMP Training,
• Assists with Warning Letter or Consent Decree remediation,
• Or provides a range of other GMP, GCP, and GLP services.

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!

DS InPharmatics LLC

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

EMD Millipore

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.

GATEWAY ANALYTICAL, LLC

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.

LABORATORY VALIDATION SPECIALISTS INC

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:

• Method Validation / Method Transfer
• Method Development
• Regulatory Consulting
• Master Plan Development
• Preparation of SOPs
• CSV - System Specifications And User Requirements Development
• Factory Acceptance Test (FAT) And Site Acceptance Test (SAT)
• Commissioning And Qualification
• Installation, Operational And Performance Qualifications (IQ, OQ And PQ)
• Process Validation, Cleaning Validation, And Computer/Software Validation
• cGMP Training Programs For Pharmaceuticals, And Biotechnology Processes
• Quality Audits – Internal and Vendor Compliance Audits

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

MCGee Pharma International

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:

• Compliance
  • Regulatory compliance evaluation and assistance
  • Quarterly Regulatory Update e-bulletin
• Inspection Readiness
  • Preparation for EU/FDA inspections
  • Mock-regulatory audits
  • Self-inspection/ internal audits
  • Third Party audits
• Pharmaceutical Quality System
  • Gap Analysis, Design and Development
• Quality Risk Management
  • Translate Regulatory Requirements
  • Define quality objectives
  • Prepare Quality Policy Manual
  • Re-define Quality Vision, Mission & Values to reflect the concepts and principles of QRM
• Tools for Quality Management 
  • Process Mapping
  • Organisation Design
• Managing Change
  • Project management of Organisational Change
• Training
  • Bespoke Training
  • 1-2-1 Coaching
  • E-learning
  • Public Workshops/Conferences
• Undressing Legislation
  • Interpretation, expert opinion/reports in litigation
• Contract QP Service
  • Technical Expertise
  • Batch Release

Microbiology Consultants, LLC

Microbiology Consultants, LLC
19009 St. Laurent Drive
Lutz, Florida 33558
Tel: +1 (727) 437-2743 (RAPID-RAPID)
E-mail: mjm@microbiologyconsultants.com
Website: http://microbiologyconsultants.com

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.

Capabilities:

• Rapid Microbiological Methods (RMM) due diligence, validation, return on investment strategies, regulatory support and in-house training
• API and fill-finish manufacturing monitoring and microbial control
• Fermentation, recovery and purification control strategies
• Sterility assurance and aseptic processing
• Environmental monitoring
• Investigations of laboratory and manufacturing microbial excursions and out-of-specification findings
• Laboratory audits, optimization and management
• Laboratory and facility design and qualification
• cGMP compliance
• Pharmacopoeial compliance
• Risk assessment
• Barrier isolator design and microbiological validation
• Microbiology method and protocol development, validation and technology transfer
• Contact lens care and ophthalmic formulation development, manufacturing, stability testing and product release
• Disinfection, sterilization and the use of biological indicators
• Regulatory audit response (e.g., FDA 483 and warning letters)
• Regulatory dossier development support
• Microbiological Process Analytical Technology (PAT)

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 mjm@microbiologyconsultants.com.

PAREXEL Consulting

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:

• Early Stage Development
• Clinical Trial Regulatory Services
• Late Stage Development
• GxP Compliance and Quality Systems
• Due Diligence (Acquisitions, Partnerships, Licensing, Outsourcing)
• Pricing and Reimbursement
• Seamless integration with PAREXEL's clinical research, medical communications and eClinical technology services and capabilities

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:

• 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 ron.kraus@parexel.com. Please mention you heard about us on the PDA Directory.

PJC Pharma Consulting, LTD

17A Cleves Road
Haverhill
Suffolk, United Kingdom
Tel: +1 (44) 7774-841319
Email: pjcpharmaconsulting@ymail.com

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.

Process Tek

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.

ProPharma Group, Inc.

10975 Benson Drive, Suite 330
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:

• Compliance and Quality Assurance
• Commissioning and Qualification
• Computer Systems Validation
• Process Validation and Cleaning Validation
• Program Management
• Project Management
• Technology Transfer and Drug Device Development
• Medical Information Services
• Corporate Compliance

Your trust means everything to us.  Call our experts at 888-242-0559, or visit us at www.propharmagroup.com.

PSC Biotech

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

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:

• experienced scientists from industry that understand today's highly regulated market challenges
• customized approach to the unique needs of every client, drug product and project
• reliable partner that is committed to meeting budget and timing requirements
• collaborative project focus from start to finish
• consistent record of GMP-compliance and quality