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