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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:
David Hall Vice President, Sales Tel: +1 (240) 688-4405 Fax: +1 (301) 986-0296 E-mail: hall@pda.org
705 Front St Toledo, OH 43605 Tel: (419) 693-5307 USA Fax: (419) 691-0418 Email: jkoenker@lexamed.net Website: www.lexamed.net
LexaMed offers consulting and laboratory services to pharmaceutical and biologics manufacturers. Our team consists of individuals with many decades of industrial experience over a wide range of specializations. We can assist in projects from a simple audit to the management and staffing to bring a product to market to a comprehensive corrective action response to a Warning Letter or Consent Decree. We offer training programs in microbiology, sterilization, investigations and CAPA, environmental monitoring, aseptic processing, Quality Systems, validation, and management.
LexaMed can introduce, implement, and administer a unique program called Operational Effectiveness Process (OEP), a closed loop operation platform designed by LexaMed to incorporate all elements of a robust quality management system coupled with manufacturing excellence, resulting in sustainable long-term benefits. The process results in focusing resources, establishing process capabilities, and instituting the measurement, monitoring, and acting of key performance indicators.
Areas of Specialization -
• Audits/Inspections • Biological Indicator Certification • Business/Leadership/Technical Management • Disinfect Efficacy Studies in Pharmaceutical Matrices • D-value Determinations • Environmental Isolate Resistance Studies • Isolator and Equipment Validation • Microbiological Research and Support Studies • Packaging Validation/closure Integrity • Process Validation • Project Management • Quality Systems/GMP • Sterilization Validation, Process Design • Training
BioCity Nottinghamm Penny Foot Street, Nottingham, N91 19F Nottingham, UK Tel: (011) 59 12 4277 Fax (011) 59 12 4278 Email: michael@pharmdservices.com Website: www.pharmdservices.com Pharmaceutical Development Services Ltd (PDS) – your gateway to Europe - provides a complete consultancy service for pharmaceutical product and medical device development and registration. This includes assistance with the development, manufacture and regulatory control of new and existing products and active ingredients and the execution of clinical trials in Europe.
Our main areas of expertise are:
• Development of regulatory strategy for clinical trials and registration • Contractor selection and management • New product introduction strategy • Clinical trial manufacturing, packaging and labelling • Medical device registration • API quality assurance and QP product release • Regulatory affairs including CTAs and MAAs • In-house Training and Development
PDS also works with a network of consultants who can provide specialist technical knowledge when required for any pharmaceutical area. Please contact Jeff Rudolph, our US representative (USA enquiries) rudolphrx@yahoo.com, or Michael Gamlen (Managing Director UK), michael@pharmdservices.com
Unit 63 Grande Close, Balooye Industrial Estate, Dublin 13 Dublin 13, Ireland Phone: +1 (353) 1 8325948 Fax: +1 (353) 1 8325949 Email: info@annmcgee.com Website: www.annmcgee.com
Ann McGee Consulting, Pharmaceutical Quality & Training Specialists Our panel of highly qualified consultants can work with you across all areas of GXP including:
• Inspection readiness • Tools for quality management • Managing change
Conferences & Workshops We provide comprehensive and rigorous technical training programmes that are designed and implemented on an on-going basis for pharmaceutical companies and through public conferences.
e-Learning • Public and bespoke training sessions • Purchased on-line through our e-learning centre • Available both live and recorded • Extremely efficient and cost effective
Regulatory Update Quarterly e-bulletin which informs our readers of developments on key legislative and best practice requirements.
TABS Our quarterly e-newsletter providing key information about new and developing issues that are of interest to the Pharmaceutical sector.
QP E-Forum A chat board facility that is integrated with our website and is available free of charge to users who register with us online.
6 Stocks Fold, East Markham, Newark, Nottinghamshire NG22 0RX United Kingdom Tel: +1 (44) 1777 872639 Fax: +1 (44) 177 872639 Email: admin@aseptd.com Website: www.aseptd.com Formed in 2001, Aseptic Technology and Design is a leading provider of skilled resources to the pharmaceutical, biopharmaceutical and medical device industries, supporting clients with the design, procurement, integration and implementation of aseptic processing, packaging & containment equipment.
Based in the UK with experience working in many countries, ATD's reputation is built on maintaining project budget, project schedule and delivering first time success.
Our wealth of experience in aseptic manufacture allows us to offer an extensive service from original concepts through to production including all aspects of design, operation and qualification of aseptic processes to FDA and EU standards.
We know that the real success of a project is determined by the output of the finished process and we have the unique ability to maximise the efficiency of a process to best suit client objectives.
We can manage an entire project, allowing the client time to make both well informed and incisive decisions or we can complement the client’s project team by plugging skills gaps to assist the client in meeting project deadlines for example, during factory acceptance testing.
ATD also pioneered the use of rapid gassing technology, using it for syringe tub transfer into an isolator with high speed filling line and went on to utilise the technology for the pharmaceutical compounding and dispensing industry which has revolutionised this business.
Offers clients assistance for regulatory submissions for US and Europe, establishing quality systems, GMP compliance, QA, QC and manufacturing systems. Services include BLA, IND and NDA submissions, regulatory submissions for post approval changes, preparations for pre- and post-approval inspections, smooth transfer from clinical to commercial operations; developing quality systems; change control; environmental monitoring; investigations; deviations; laboratory systems; process characterizations; monitoring and PAT; Microbiology validation; auditing; vendor qualification system; corporate policies; documentation systems; 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.
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.
Compliance Insight, Inc. specializes in Regulatory and Quality Assurance consulting and training for pharmaceutical, medical device, and bio-technology companies worldwide.
We have been helping companies, large and small, with their regulatory compliance and quality assurance challenges since 2000. Our dedicated team has over 100 years of combined knowledge and experience in FDA-regulated industries. Our goal is to provide a proactive, hands-on solution to your regulatory and compliance needs.
AREAS OF EXPERTISE
Biosafety and Viral Testing Compliance • sterility, mycoplasma, and viral testing for raw materials, process intermediates and final products • viral clearance and cleaning validation studies • raw materials testing • analytical and stability testing GMP Auditing • General Assessment • GAP Analysis • Full Audits • Vendor/Contract Mfg • PAI Preparation • Due Diligence Customized GMP Training Quality Assurance Accreditation Validation Planning Cleaning Validation SOP Writing FDA Mock Inspections Investigations CAPA FDA Response Assistance
Complya’s consultants provide Quality Assurance and Regulatory Affairs services that increase your compliance and lighten your workload.
Not every consultant is right for every job, so our collective experience ensures that the right consultant is working on every project. Our roster of consultants ranges from strong mid-level talent to some of the highest skilled, senior-level talent in the industry.
Whether you need a consultant to back-fill a position left by employee attrition, help in becoming more FDA or globally compliant, or just lighten your day-to-day workload, we roll up our sleeves and deliver results.
Our core services include:
GMP Consulting:
§ Development of quality systems
§ Internal and External GMP Audits
§ SOP Generation and Revision
§ Personnel Training and GXP (GMP/GLP/GCP) Training
§ Person-in-plant Quality oversight
§ Batch record review
§ Validation review (IQ/OQ/PQ, Process Validation, Cleaning Validation)
§ Stability program management
§ PAI preparation
Clinical Oversight/GCP:
§ QA oversight of Clinical Data Management
§ Clinical investigator audits
§ CRO selection and management audits
§ Central clinical file audits
§ Clinical document review
§ SOP generation
§ IVRS oversight
§ Clinical site selection, initiation, and monitoring
§ Medical writing
Laboratory Compliance/GLP Services:
§ Contract laboratory selection and management
§ Laboratory inspections and in-process audits
§ Protocol and report review
Regulatory Affairs Consulting:
§ Preparation of Regulatory Filings
§ Regulatory Operations and PM of filings
§ Change assessment
§ Labeling review
§ Advertising & Promotional Material review
Complya won’t leave you with longer to-do lists. We leave you with a more efficient and more compliant operation.
Pharmaceutical, Biotech & Food US-Asia Pacific Contract Services Chicago • Philadelphia • Shanghai Silver Centre 1388 North Shan Xi Road Shanghai 200060 China T: 86.21.6149.8049 F: 86.21.6149.8099 T: 877-355-9950 (US) F: 215-358-0751 (US) Email: info@csrpharmsvcs.com Http: www.csrpharmsvcs.com
CSR provides pharmaceutical services in quality, regulatory, and commercialization for the development and marketing of products. Our Quality services include Suppliers Third-Party auditing, compliance monitoring, development/improvement of Quality System and other FDA-Inspection Systems, cGMP training. We can provide scientific assistance with preparation of regulatory responses, representation and/or liaison in negotiations with the FDA, and preparation of regulatory submissions. Our core expertise is based on over 80 years of management experience working in the U.S. pharmaceutical industry, with Big Pharma companies, and interacting with the U.S. FDA at the Centers and District Offices. Our primary Asia-Pacific focus is the Greater China Region. We work in the language and understand the culture of the markets we serve.
Custopharm, Inc. 1902 Wright Place, Suite 200 Carlsbad, CA 92008 Tel: +1 (760) 481-7811 or +1 (760) 481-7590 Fax: +1 (760) 301-0048 Email: busdev@custopharm.com Website: www.custopharm.com CUSTOpharm, Inc.
Efficient—Effective—Economical
Custopharm, a service company, provides cost-effective CMC and regulatory support. Custopharm has fully developed and filed many products with the US FDA. Custopharm is an industry leader in eCTDs and Gateway filings:
Over 65 eCTD submissions since 2004 Over 125 Gateway Filings since May 2008
Custopharm provides:
Product and Dosage Form Development for INDs, NDAs, ANDAs Sourcing of Product Manufacturing Technology Transfer Robust and Scalable Lyophilization Development Project Management Comprehensive Regulatory Support Services U.S. Agent Services eCTD Submission Services via the ESG for INDs, DMFs, NDAs, ANDAs Training service to convert companies to eCTD submissions without need for expensive software Assistance with new electronic Drug Listings and SPL requirements
45 Capner Street, Suite A Flemington, NJ 08822 Phone: 1+ (877) cGMP-211 Fax: 1+ (877) 932-9828 Email: validation@ddcvalidation.com Website: www.ddcvalidation.com D & D Consulting LLC., offers a full-range of validation and compliance services for your cGMP/GLP facility. Our validation professionals have over 15 years of hands-on experience in Facility Design and Construction, Utilities, Process Equipment and Qualification. We have the expertise and commitment to provide the superior service required to meet all of your validation and compliance needs. Dedication to quality, personalized support and the success of your projects are the foundation of our company. Our Team will deliver effective planning, teamwork, communication and project controls required to successfully complete your project. Our employees have the hands-on experience and depth of knowledge to ensure compliance with the applicable regulations and clients requirements. D & D Consulting LLC has successfully managed many pharmaceutical and biotechnology projects that include design review, construction qualification, commissioning, validation, and regulatory support. As a result, we’ve become a valuable asset in helping to meet your expectations of quality, cost efficiency, schedule and safety. The success of our project is based on developing partnerships with our clients to ensure their project goals are achieved. We begin and end the project with your product in mind. We have a deep understanding of the process, procedures and documentation required to support your facility. All documentation produced to support your process is compliant with all QA and Regulatory requirements and procedures.
Services: Cleaning Validation Commissioning and Laboratory Startup Computer Validation Preparation for FDA/EU Inspections Process Validation Project Management Risk Assessment and GAP Analysis Sterilization Thermal Mapping Utility and Equipment Qualification Validation Master Planning
Eakins & Associates is dedicated to providing technical guidance to biotechnology and pharmaceutical companies in the selection of primary packaging for parenteral products, particularly glass and plastic pre-filled syringes, and the development of pharmaceuticals in these containers.
Primary Packaging:
- Selection of Container Vendors - Differentiation of Glass and Plastic Pre-fillable Syringes - Cyclic Olefin Selection - Product Development in Glass and Plastic Pre-filled Syringes and Vials - Selection of Container Extractables & Leachables - Pharmacopeial Packaging Guidance - Compliance with International Regulatory Requirements - Identification of Syringe Filling CMOs - Compliance with Cold Chain Distribution Requirements - Addition of Authentication and Track and Trace Technologies - Glass and Plastic Container Workshops
Drug Development:
- Stability Protocols - Drug Master Files
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.
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.
C/Baeza 5 28002 Madrid, Spain Phone 1+ (34) 914153801 Fax: 1+ (34) 915191849 Email: susanne.jensen@reigjofre.com Website : www.reigjofre.com
Founded in 1929 Reig Jofré Group, is a leader at the Spanish industrial pharmaceutical market. Specialist in contract manufacturing, our services include dossier development and licensing out globally, biotechnology and branded pharmaceutical companies. With 3 plants in Europe and more than 500 employees, our capabilities cover products in different dosage forms, specialised capabilities in aseptic filling, lyophilisation, ß-Lactams and Cephalosporins. Reig Jofré‘s dedicated client service team working for more than 160 clients worldwide, from large multinationals to small-medium size local firms.