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