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Search Terms:Company Category= Industry Service Provider-Regulatory Consulting | Labeling| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 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. |