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Search Terms:Company Category= Industry Service Provider Regulatory Consulting| Alpha Pharm Tech P.O. Box 669 Bear, DE 19701 0669 302-834-3344 Larry Hughes webmaster@alpha-engineering.com www.alpha-pharm.com Alpha Pharm Tech provides decontamination services superior to older, unreliable, and unsafe methods such as paraformaldehyde gassing and chlorine bombs. Aggressive cleaning procedures, rotating disinfectant solutions, and Space/Equipment Decontamination processes keep microbial counts under control. Alpha Pharm Tech’s Engineers and Cleanroom Technicians are familiar with relevant Code of Federal Regulations as well as with current Good Manufacturing Practice (cGMP). |
| AMEC One Plymouth Meeting Suite 850 Plymouth Meeting, PA 19462-1308 610-877-0001 Charles A. Clerecuzio, PE charles.clerecuzio@amec.com www.amec.com/pharmaceuticals AMEC is an international, engineering, environmental, commissioning, validation, and cGMP compliance consulting company focused on the API, pharmaceutical, and biotechnology industries. We specialize in clinical and commercial laboratory and sterile production facilities. Our expertise encompasses process engineering and validation for manufacturing dosage form and bulk end-products. We can execute a turnkey facility project from conceptual design and engineering through final Establishment Licensing Agreement (ELA) application. |
| Apyx, Inc. 709 Main Street Suite 220 Schwenksville, PA 19473 610-287-2140 Mike Bradly info@apyx.com www.apyx.com Apyx specializes in the delivery of Regulatory solutions to the Life Science industry. Apyx offers a suite of services and tools designed to empower our sponsors in the creation and management of Regulatory documents and submissions. Apyx consults extensively on building eCTD submissions and management of the eCTD lifecycle. |
| Axendia, Inc. 668 Stony Hill Road Suite 316 Yardley, PA 19067 215-262-8037 Daniel R. Matlis info@axendia.com www.axendia.com Axendia is a leading analysis firm focused strictly on the life-sciences market. Our Mission is to be the most trusted advisor to life-science executives on business, regulatory and technology issues. Axendia provides a unique combination of hands on experience coupled with strategic vision. We provide the insight you need to make educated decisions in this complex and highly regulated industry. |
| BE&K Engineering BE&K BioPharm 242 Chapman Road Newark, DE 19702 302-452-9063 Mary Lou Briggs briggsm@bek.com www.bek.com BE&K is an engineering consulting firm with expertise in designing for facilities and processes for the biotech industry. BE&K also specializes in construction management, commissioning and validation for the biopharmaceutical and medical device industries. We have extensive experience in GMP and regulatory compliance and have assisted many of our clients in navigating through the regulatory maze. |
| BioPortUSA 620 Lee Road Suite 130 B Wayne, PA 19087 610-725-0290 x 423 Jim Laird (CEO) info@bioportusa.com www.bioportusa.com BioPortUSA is the commercialization accelerator uniquely positioned to assist foreign-based life science companies enter the US market. Core services include commercialization assessment and plan development, executive recruitment, legal, accounting/audit/tax, real estate, clinical trial management, risk management insurance, and commercialization funding. |
| BioVerum Partners, LLC 1101 Green Valley Road Bryn Mawr, PA 19010 888-600-1999 Susan Thornton sthornton@bioverumpartners.com www.bioverumpartners.com BioVerum Partners, a healthcare advisory service firm, offers a single source for all strategic and tactical program support. Our comprehensive capabilities enable us to assist our clients as a Virtual Management Team. Services include Management Consulting (financial, business, operations, marketing); Product Development (clinical strategy, vendor management, regulatory services); and Business Alliances (due diligence, out-licensing and divestiture, in-licensing and acquisition). |
| BPS Consultng, Inc. 901B East Willow Grove Avenue Wyndmoor, PA 19038 215-836-7290 Tina M. Kell tkell@bpsolutionsinc.com www.bpsconsultinginc.com BPS Consulting’s staff of Recruiters and Career Counselors spends everyday building relationships with talented individuals. Our goal is to completely understand the career objectives and skills of everyone we meet. We can very quickly identify highly qualified candidates for any full time or contract Executive, Technology or Administrative position. |
| CanReg, Inc 53 Treaty Drive Wayne, PA 19087 610-408-0882 Diane Turkin, Ph.D. dturkin@canreginc.com www.canreginc.com Regulatory consulting for the biological/biotechnology, pharmaceutical, and medical device industries. Worldwide reach, including US, EU and Canada. |
| CDI-Life Sciences 1801 Market Street Suite 1300 Philadelphia, PA 19103-1605 215-282-8740 Brian White Brian.White@cdicorp.com www.cdi-lifesciences.com CDI-Life Sciences provides a full range of engineering, design, construction management, commissioning, and validation services Our professionals have expertise in the design, construction, and validation of biotech, bulk API, pharmaceutical, fill-finish and solid dosage research, development and manufacturing facilities that are compliant with US-FDA, EU-EMEA, and other worldwide regulatory requirements. |
| Clarkston Consulting 200 Barr-Harbor Drive Suite 400 West Conshohocken, PA 19428 610-941-2737 Paul W. Allen, Vice President, Life Sciences greaterphila@clarkstonconsulting.com www.clarkstonconsulting.com Clarkston Consulting, a leading management and technology consulting firm, specializes in the life sciences industry. We've helped market leaders across the Philadelphia region bridge the gap between operational efficiency and compliance, increase speed-to-market, and improve their bottom line. Our proven expertise in areas such as regulatory and remediation, commercial compliance, quality systems, and operational excellence, has resulted in a 99% client satisfaction rating. |
| CRB Consulting Engineers 220 West Germantown Pike Suite 170 Plymouth Meeting, PA 19462 610-278-7644 Shannah Schodle shannah.schodle@crbusa.com www.crbusa.com CRB provides engineering, architectural and related services to the life science industry in all areas of project execution. Services include front-end consulting; mechanical, electrical, chemical, and process engineering; architectural and instrumentation design; testing and balancing (NEBB certified); plus commissioning and start-up assistance. Our client list includes the top 100 biopharmaceutical companies. |
| DataCeutics, Inc. 1610 Medical Drive Suite 300 Pottstown, PA 19464 610-970-2333 Suzette James jamessu@dataceutics.com www.dataceutics.com DataCeutics is the leader in human research information technology. We provide support and services for data systems used within the life sciences industry. Our sole business focus is the delivery of expert consulting services from our service units of Compliance, Clinical Data Management, and Regulatory Reporting. DataCeutics builds client relationships predicated on quality, and on the value of our services and software products. |
| Day & Zimmermann Validation Services 1818 Market Street Philadelphia, PA 19103 215-299-8796 Philip Clark philip.clark@dayzim.com www.dayzim.com Day & Zimmermann has highly competent technology specialists that deliver expertise for a complete portfolio of qualification, systems validation, regulatory compliance and quality assurance services to pharmaceutical, biotechnology and medical device companies worldwide. With a track record spanning three decades, our experience and risk management programs ensure that we stay ahead of our competition so our customers can stay ahead of theirs. |
| Exponent, Inc. 3401 Market St Suite 300 Philadelphia, PA 19104 215-594-8874 Kevin Ong MedDev@exponent.com www.exponent.com Exponent is a leading engineering and scientific consulting firm with expertise in regulatory support, product design evaluation, failure analysis, safety and risk assessment, epidemiological services, economic assessments, root cause analyses for recalls, manufacturing operations support, tissue analysis, intellectual property evaluations, and technical litigation support for many disciplines, including medical devices. We provide rapid, focused, market-sensitive solutions to complex matters. |
| Falcon Consulting Group One East Uwchlan Avenue Suite 300 Exton, PA 19341 610-363-0815 John Lowman lowmanj@falconnest.com www.falconnest.com Falcon provides services in Good Clinical Practices (GCP) and Technical QA (Including Part 11 Compliance and Validation). |
| Flaster/Greenberg P.C. 1628 JFK Boulevard Philadelphia, PA 19103 215-279-9375 Lynda Calderone, Joseph DiDonato, Janet Levine lynda.calderone@flastergreenberg.com www.flastergreenberg.com Full service law firm in NJ, PA & DE. Expertise in patent and trade secret law; trademark and copyright law; IP litigation; employment, licensing, joint ventures, and mergers and acquisitions; research and development agreements; non-disclosure, settlement and intellectual property portfolio management and strategy; e-commerce agreements and domain name disputes; business and corporate services; labor and employment; taxation; employee benefits; environmental law, and real estate. |
| Genesis Engineers, Inc. 1850 North Gravers Road Plymouth Meeting, PA 19462 610-592-0280 Donna A. DeFreitas ddefreitas@geieng.com www.geieng.com Genesis Engineers (GEI) is a full service project delivery firm providing expert engineering, construction and commissioning services for technically driven projects. Our “engineering led” focus sets GEI apart and enables GEI to be a leader in the field of project delivery. Visit our website for more information on our services and project experience: www.GEIeng.com. |
| Hubbell Consulting, LLC 137 Greentree Road 3rd Floor Turnersville, NJ 08012 856-232-6308 Howard R. Hubbell, Ph.D. howard.hubbell@hubbell-consulting.com www.hubbell-consulting.com Hubbell Consulting, LLC provides regulatory consulting, clinical trial management, and medical/regulatory writing services to the pharmaceutical, biotechnology, and medical device industries, and CROs. We have over 20 years of experience and expertise in research and development, and regulatory affairs. We focus on clients' needs, adhering to timelines and upholding the values of accountability, confidentiality, expertise, excellence, integrity, and reliability. |
| ICON Development Solutions 212 Church Road North Wales, PA 19454 215-616-3000 Paul Washart washartp@iconus.com www.icondevsolutions.com With expertise in clinical pharmacology, regulatory affairs, pharmacokinetics, biopharmaceutics, and bioanalytical, ICON Development Solutions specializes in the strategy, management and execution of product development and early phase clinical development. ICON Development Solutions has the operational flexibility to deploy the right resources to meet our sponsor’s specific needs, whether these needs are driven by timeline, expertise required or location. |
| Innovative Consulting Partners, LLC 475 Painter Way Lansdale, PA 19446 215-901-4354 Steve Pugliese srpugliese@ic-partners.com www.ic-partners.com ICP brings proven experience collaborating with some of the world's most dynamic companies to cultivate ideas, leverage industry best practices and deliver optimal business results. ICP develops new business models to improve the speed and efficiency of organizations. ICP consultants are skilled in process engineering and regulations in addition to clinical, regulatory, manufacturing and consulting methodologies that enable you to meet or exceed your goals. |
| inVentiv Clinical Solutions 5 Great Valley Parkway Suite 259 Malvern, PA 19355 610-644-7963 Blythe Vito info@inventivclinical.com www.inventivclinical.com inVentiv Clinical Solutions provides unique clinical outsourcing solutions, allowing the greatest flexibility through unmatched access to high quality clinical resources. We provide clinical trial management and monitoring, biostatistics and data management solutions, regulatory consulting and liaison services, and patient and investigator recruitment, complimented by industry leading staffing capabilities. (www.inVentivClinical.com) |
| inVentiv Health Vantage Court North 200 Cottontail Lane Somerset, NJ 08873 800-416-0555 Paul Mignon businessdevelopment@inventivhealth.com www.inventivhealth.com inVentiv Health (NASDAQ: VTIV) is the leading provider of commercialization and complementary services to the global pharmaceutical, life sciences and biotechnology industries. inVentiv delivers its customized clinical, sales, marketing and communications solutions through its three core business segments: inVentiv Clinical, inVentiv Communications and inVentiv Commercial. inVentiv Health currently works with over 200 unique pharmaceutical, biotech and life sciences clients, including all top 20 global pharmaceutical companies. |
| IPS - Integrated Project Services 2001 Joshua Road Lafayette Hill, PA 19444 610-828-4090 Kimberly Goodman kgoodman@ipsdb.com www.ipsdb.com Integrated Project Services (IPS), www.ipsdb.com, is a full-service engineering firm servicing the pharmaceutical and biotechnology industries as well as medical device, diagnostics and specialty chemical. IPS services include technical consulting, engineering and design, design/build, construction management, commissioning, and compliance. Located in Lafayette Hill, PA, IPS has full service branch offices in Pennsylvania, North Carolina, New Jersey, California, Indiana, Puerto Rico and India. |
| Lenape Associates, Inc. 406 Lloyd Avenue Suite 200 Downingtown, PA 19335 610-269-6812 Jim Spaulding info@lenapeassociates.com www.lenapeassociates.com Founded in 1995, Lenape Associates enjoys the respect and confidence of such clients as: AstraZeneca, Centocor, sanofi-aventis, GlaxoSmithKline and Wyeth. In addition to successful product development and installations for Clinical Study and Trial Support, we also provide database design and management, statistical analysis, office automation, user training and support, project management – often as a liaison with clinical research organizations. |
| Liquent, Inc. 101 Gibraltar Rd Horsham, PA 19044 215-328-4444 James Nichols liquent.info@thomson.com www.liquent.com Liquent is the global leader in providing regulatory information management solutions and related services for the life sciences industry. Liquent’s software and service offerings help to ensure that clients meet the strict standard of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time. |
| Maguire Laboratory Animal Veterinary Services 7505 Woodlawn Avenue Elkins Park, PA 19027 215-605-7326 Sean Maguire maguiresean@gmail.com http://www.linkedin.com/pub/sean-maguire/3/70/208 Providing attending veterinarian services- experienced with AAALAC, AWA, IACUC and GLPs. ACLAM boarded. |
| MPP BioDesigns 204 Orlando Ave Oreland, PA 19075 215-740-0638 Marc Pelletier mpelletier@mppbiodesigns.com www.mppbiodesigns.com Offering process and facility design and programming consulting services. Compliance, risk assessments, validation, start-up and commissioning. |
| O'Brien & Gere 512 Township Line Rd. Two Valley Square, Suite 120 Blue Bell, PA 19422 215-628-9100 John Kurtz KurtzJE@obg.com www.obg.com O'Brien & Gere's integrated team designs and builds R&D, pilot plant, and clean manufacturing facilities for the biotechnology and pharmaceutical industries. We help our clients improve their COGS by helping them improve energy efficiency and sustainability practices related to their facilities and the related utilities & infrastructure. We also help assess, monitor and remediate environmental issues in operations and facilities to help maintain compliance in a complex regulatory environment. |
| PA Consulting Group 600 College Road Suite 1120 Princeton, NJ 08540 609-806-0800 Dan Walsh dan.walsh@paconsulting.com www.paconsulting.com PA's healthcare capability spans technology development, delivery, and consulting services for life science companies through to healthcare delivery and reform. Our global pharmaceutical and biotechnology consultancy services focus around commercial excellence, R&D effectiveness, and supply chain performance. In addition, our 200 scientists and engineers design, develop, and deliver pharmaceutical products, drug-delivery devices, and novel scientific instruments. |
| Penn Pharmaceutical Services 1546 E. Cobblestone Circle Warrington, PA 18976 610-701-0980 James Knapp james.knapp@pennpharm.com www.pennpharm.com Penn Pharmaceutical Services is a leading provider of fully integrated and cost effective pharmaceutical development and custom manufacturing services to the international healthcare industry, whose services support a fast and effective route from clinic to market. Penn Pharmaceutical Services provides unparalleled service offerings developed over its 30 year history. |
| Pharma Growth Strategies LLC 13 Summit Square Center #132 Langhorne, PA 19047-1098 215-860-3336 Fredric Cohen fred@pharmagrowth.com www.pharmagrowth.com Specialized life science management consultant, focused on strategic planning for new product development and licensing. |
| Philip J. Cross & Associates, Inc. 3010 Faulkland Road Wilmington, DE 19808 302-633-9404 Philip J. Cross pjcross@verizon.net Our consultants are experts in biopharmaceuticals and biotechnology. We will assist you plan your product development program from "benchtop to bedside." We can help you establish a Quality System and prepare INDs, DMFs, SOPs, and other regulatory documents so you can initiate clinical studies quickly. We also have extensive experience in manufacturing facilities, operations, preclinical studies, and clinical development. |
| pjmathison 2037 Chestnut Street Box 30583 Philadelphia, PA 19103 215-755-4578 Randy Santo randy.santo@pjmathison.com www.pjmathison.com pjmathison, est. 1990, provides government affairs and strategic management consulting services to institutional clients worldwide. The firm also produces, sells and licenses for resale government technology investment forecasts. |
| Porzio Governmental Affairs, LLC Capitol Complex Executive Center 172 West State Street Trenton, NJ 08608-1104 609-396-6100 Dennis F. Marco dfmarco@porziogovaffairs.com www.porziogovaffairs.com Porzio Governmental Affairs assists clients with legislative and regulatory matters in New Jersey and the District of Columbia. Our professionals help clients interact effectively with legislators and regulators, and provide information on industry, legislative and regulatory developments. |
| Porzio Pharmaceutical Services 100 Southgate Parkway P.O. Box 1997 Morristown, NJ 07962-1997 973-538-1690 Linda Pissott Reig reig@porziopharma.com www.porziopharma.com Porzio Pharmaceutical Services offers a portfolio of products and services to help companies remain compliant with complex federal and state regulations governing marketing and sales in the life sciences industry. Our products and services are also designed to enhance the productivity and efficiency of the sales and marketing programs of our pharmaceutical, biotech and medical device clients. |
| Punch Media 7151 Sprague Street 3rd Floor Philadelphia, PA 19119 215-621-6024 Roy Payne or James Zeleniak roy@punchmedia.biz www.punchmedia.biz Punch Media is a Philadelphia-based public relations and marketing company offering both local expertise and international reach to better communicate your message. Our strong suit is targeting European markets for business development and media management. We offer public relations and consulting services for businesses seeking increased presence in Philadelphia as well as those seeking additional revenue sources from abroad. Call 215-621-0624; www.punchmedia.biz. |
| QS Pharma LLC 3 Chelsea Parkway Suite 305 Boothwyn, PA 19061 610-485-4270 x13 Michael B. Maurin, R.Ph., Ph.D. michael.maurin@qspharma.com www.qspharma.com QS Pharma is founded on the tenet of Quality with Speed™. Our focus is on the provision of contract services to biopharmaceutical and pharmaceutical companies for the formulation and analytical research and development process from NCE screening through clinical supply and submission batch manufacture and scale up. Services include clinical supply manufacture and all facets of analytical testing and stability. |
| QSE Pharma Consulting 119 Hunt Club Drive Collegeville, PA 19426 484-432-9007 John J. Savarese, M.D., Ph.D. savarej@comcast.net www.QSEPharma.com QSE Pharma Consulting provides advice and information on the Quality, Safety, and Efficacy aspects of pharmaceutical development. Regulatory and clinical research consulting covers trial design through registration submissions across therapeutic areas. Consultation is available on manufacturing and safety testing, and on health authority initiatives including biosimiliars, biomarkers, risk management, and continuous quality improvement. Drug development expertise covers the FDA, the EMEA, and other health authorities. |
| QuinTech Resources, Inc. 625 North Governor Printz Blvd. Suite 4 Essington, PA 19026 610-362-1400 Mark Trottnow mtrottnow@quintechresources.com www.quintechresources.com QuinTech provides temporary/contract and permanent staffing assistance and solutions for our clients. We have a proven record in Information Technology and Validation Services for our clients in Life Sciences. |
| Rebbeson, Inc. 150 Somerset Drive Blue Bell, PA 19422 215-519-9271 Marvin I. Siegel, Ph.D. msiegel@rebbeson.com www.rebbeson.com Rebbeson provides consulting services to entrepreneurs and entrepreneurial companies. Rebbeson can provide guidance in strategic planning, organizational development, business development, and angel and venture capital fund raising. Based on significant experience in discovery, pre-clinical research, biological process development, clinical and regulatory affairs as well as project management, Rebbeson can help formulate strategies and guide development of drug candidates from discovery through approval. |
| Recruitech International 355 Business Center Drive Suite 150 Horsham, PA 19044 215-293-1300 Jennifer DiLauro jdilauro@recruitech.com www.recruitech.com Recruitech International is the foremost leader in Clinical Development Staffing, providing Temporary, Temp to Perm and Permanent Staffing in all areas of the Clinical Trials process. Our Guaranteed Success ratio is backed by an unbeatable database of fully pre-screened Industry professionals and the best relationships in the business. |
| Sentrx Overlook at Great Notch 150 Clove Road Little Falls, NJ 07424 888-399-8032 Jill Notte jill.notte@sentrx.com www.sentrx.com Sentrx delivers comprehensive pharmacovigilance solutions for clinical trial safety, post-marketing safety surveillance and risk management programs. Drug Safety Services from Sentrx help pharmaceutical, biotechnology, medical device, consumer health and dietary supplement companies document the safety profile of their products during clinical development and post-approval, enabling clients to minimize risk and maximize benefits. |
| The CECON Group, Inc. 242 N James St #202 Wilmington, DE 19804 302-994-8000 Boyd Sorenson cecon@cecon.com www.cecon.com Technical consultant provider with technical specialists in manufacturing (fermentation, mixing, extraction, drying, general chemical engineering), molecular biology, medicinal chemistry, formulation, controlled release and all aspects of FDA compliance and validation. |
| The Practical Solutions Group, LLC 152 Witherspoon Street Princeton, NJ 08542 609-683-0756 Len Grunbaum ebarsky@practicalsolutionsnj.com www.practicalsolutionsnj.com “Providing a regulatory observation without a business context is like serving coffee without a cup (sm)”. The Practical Solutions Group, LLC was born to pursue the vision that every regulatory deficiency issue results from an operational problem. We assist Company Management in the Pharmaceutical, Biotechnology and medical device industries to avoid both. |
| The Weinberg Group Inc. 212 Carnegie Center Suite 206 Princeton, NJ 08691 609-919-6373 John C. (Jack) Garvey, Esq. john.garvey@weinberggroup.com www.weinberggroup.com The Weinberg Group is an international scientific and regulatory consulting firm that helps companies support their product at every stage of its life. We help our clients improve manufacturing processes, address regulatory requirements, and support products in the courts and the media. |
| Tunnell Consulting 900 E. Eighth Avenue Suite 106 King of Prussia, PA 19406 610-337-0820 Conrad Heilman, Ph.D. heilman@tunnellconsulting.com www.tunnellconsulting.com Tunnell Consulting, founded in 1962, is a globally-positioned management consulting and implementation firm whose expertise improves the operating performance of each client we serve. With a focus in the areas of pharmaceuticals, biotech, biologics, and medical devices, we integrate strategic, technical, process and organizational skills to design sustainable solutions for our clients. |