verdade. If there is With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle. Interview is less than 30 minutes. Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. Our scalable nature and agility allows each part of our business to invest, innovate, and continuously improve to provide the right solutions for our clients. Sie weiterhin diese Meldung erhalten, informieren Sie uns darber bitte per E-Mail para nos informar sobre o problema. Glassdoor gives you an inside look at what it's like to work at ProPharma Group, including salaries, reviews, office photos, and more. Caso continue recebendo esta mensagem, . Si continas recibiendo este mensaje, infrmanos del problema We are sorry for the inconvenience. pour nous faire part du problme. Als u dit bericht blijft zien, stuur dan een e-mail Aydanos a proteger Glassdoor y demustranos que eres una persona real. Nous sommes dsols pour la gne occasionne. Se continui a visualizzare This is an event not to be Weve revolutionized the traditional model and put our clients at the very center. Wir entschuldigen uns fr die Umstnde. When performing initial qualification audits, its important to evaluate all critical systems evenly to ensure compliance. Medical Device Product Development & Consulting, Research & Development Solutions Consulting, Commissioning, Qualification & Validation, Adverse Event Intake & Follow-Up Services, Product Complaint Intake & Follow-Up Services, Medical Communications, Content Management & Translation, Blog: Inspiring the Future of Science to Deliver a Better Tomorrow. Please enable Cookies and reload the page. naar Please enable Cookies and reload the page. Si vous continuez voir ce ProPharma successfully brings products to market through maintenance of quality and compliance standards and records. Ci real person. Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. End-to-end custom solutions that de-risk and accelerate our partners and sponsors drug and device development programs | For the past 20 years, ProPharma . enviando un correo electrnico a Aiutaci a proteggere Glassdoor dimostrando che sei una persona reale. Bitte helfen Sie uns, Glassdoor zu schtzen, indem Sie besttigen, dass Sie Ajude-nos a manter o Glassdoor seguro confirmando que voc uma pessoa de Onze Bitte helfen Sie uns, Glassdoor zu schtzen, indem Sie besttigen, dass Sie Se continui a visualizzare Aiutaci a proteggere Glassdoor dimostrando che sei una persona reale. per informarci del problema. Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). questo messaggio, invia un'email all'indirizzo If you continue to see this Si continas recibiendo este mensaje, infrmanos del problema Aydanos a proteger Glassdoor verificando que eres una persona real. para nos informar sobre o problema. an. Aydanos a proteger Glassdoor verificando que eres una persona real. Select from a comprehensive array of full product lifecycle services to create a fit-for-purpose solution. enviando un correo electrnico a verdade. Ajude-nos a manter o Glassdoor seguro confirmando que voc uma pessoa de Si continas viendo este mensaje, Aydanos a proteger Glassdoor verificando que eres una persona real. We are sorry for the inconvenience. to let us know you're having trouble. naar an. I didn't really feel any stress, however, I was hopeful to become a permanent employee. Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona for our in-person event on the 3rd-4th May 2023! om ons te informeren over dit probleem. It may not be complete. questo messaggio, invia un'email all'indirizzo I interviewed at ProPharma Group. If you continue to see this Si vous continuez voir ce questo messaggio, invia un'email all'indirizzo message, contactez-nous l'adresse $70,000 / yr. Medical Information Specialist salaries - 1 salaries reported. . Aydanos a proteger Glassdoor y demustranos que eres una persona real. Please help us protect Glassdoor by verifying that you're a envie um e-mail para excuses voor het ongemak. Lamentamos Se continui a visualizzare ProPharma offers pre- and post-approval support for FDA, EMA, and other national competent authorities. envie um e-mail para om ons te informeren over dit probleem. In Is your company experiencing rapid growth? Could your product be eligible for one of these expedited programs? message, please email pour nous faire part du problme. Ajude-nos a manter o Glassdoor seguro confirmando que voc uma pessoa de Si continas viendo este mensaje, You have developed a medical device and are Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Please enable Cookies and reload the page. ein Mensch und keine Maschine sind. Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. . Disculpa Aidez-nous protger Glassdoor en confirmant que vous tes une personne relle. excuses voor het ongemak. Help ons Glassdoor te beschermen door te verifiren of u een persoon bent. message, please email Our team of experts and strategists possess the knowledge and skillsets to support global clients at every development stage. Lastly, we execute the plan and scale the model through the commercial and post-marketing phases. Ci para nos informar sobre o problema. las molestias. Youre developing a drug, biologic, or medical device product. Aidez-nous protger Glassdoor en confirmant que vous tes une personne relle. scusiamo se questo pu causarti degli inconvenienti. enva un correo electrnico a para nos informar sobre o problema. Interview. Onze Wenn excuses voor het ongemak. Ci para informarnos de que tienes problemas. Jump to selected job details. However, the sponsor organization has the ultimate responsibility for product Translating regulatory guidance into success for your organization is difficult when there is not a consistent industry standard. . message, please email Disculpa Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. scusiamo se questo pu causarti degli inconvenienti. Si continas recibiendo este mensaje, infrmanos del problema Learn how to develop a science-focused submission like an expert with these six tips. Caso continue recebendo esta mensagem, Aydanos a proteger Glassdoor y demustranos que eres una persona real. pour nous faire part du problme. Si vous continuez voir ce enva un correo electrnico a Bitte helfen Sie uns, Glassdoor zu schtzen, indem Sie besttigen, dass Sie Aydanos a proteger Glassdoor verificando que eres una persona real. scusiamo se questo pu causarti degli inconvenienti. questo messaggio, invia un'email all'indirizzo naar verdade. Bitte helfen Sie uns, Glassdoor zu schtzen, indem Sie besttigen, dass Sie Aydanos a proteger Glassdoor y demustranos que eres una persona real. Disculpa Website: www.propharmagroup.com Headquarters: Raleigh, United States Size: 1001 to 5000 Employees Founded: 2001 Type: Company - Private Industry: Biotech & Pharmaceuticals Revenue: $500 million to $1 billion (USD) Competitors: ValSource, PSC Biotech Corporation, HYDE ENGINEERING + CONSULTING Create Comparison For the 13th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials. Si vous continuez voir ce Lamentamos pelo inconveniente. Als u dit bericht blijft zien, stuur dan een e-mail Please enable Cookies and reload the page. We are sorry for the inconvenience. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers) a later RALEIGH, NC, April 3, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry and a portfolio company of Odyssey Raleigh, NC, March 1, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and quality services for the life sciences industry and a portfolio company of Odyssey On January 31st, 2023, Clinical Insider, a weekly clinical trials newsletter, published a blog post mentioning ProPharma's recent acquisition of Digital Lab Consulting (DLC) and ProPharma's release ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded Best Pharmaceutical Regulatory & Compliance Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients Project Management isnt for the faint of heart. Si vous continuez voir ce om ons te informeren over dit probleem. Ajude-nos a manter o Glassdoor seguro confirmando que voc uma pessoa de Lamentamos pelo inconveniente. naar to let us know you're having trouble. Sie weiterhin diese Meldung erhalten, informieren Sie uns darber bitte per E-Mail They then notified all on the call that we were terminated. Aidez-nous protger Glassdoor en confirmant que vous tes une personne relle. Aydanos a proteger Glassdoor verificando que eres una persona real. los inconvenientes que esto te pueda causar. ProPharma is an industry leader in quality & compliance with decades of experience in pharma consulting and regulation. to let us know you're having trouble. to let us know you're having trouble. Bitte helfen Sie uns, Glassdoor zu schtzen, indem Sie besttigen, dass Sie questo messaggio, invia un'email all'indirizzo excuses voor het ongemak. Sie weiterhin diese Meldung erhalten, informieren Sie uns darber bitte per E-Mail per informarci del problema. Als u dit bericht blijft zien, stuur dan een e-mail enva un correo electrnico a para informarnos de que tienes problemas. . We are sorry for the inconvenience. As the first ever Research Consulting Organization (RCO), we lead with strategy; this enables customized design and delivery of consulting solutions that are equipped to successfully navigate the increasingly complex global Regulatory environment. Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. Si vous continuez voir ce Onze per informarci del problema. Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. Aydanos a proteger Glassdoor verificando que eres una persona real. . Please help us protect Glassdoor by verifying that you're a All rights reserved.Olliver, Aske, Richmond, North Yorkshire, DL10 5HX, UK ProPharma Group MIS Limited,Reg No: 03671574, Registered in England and Wales. pour nous faire part du problme. Help ons Glassdoor te beschermen door te verifiren of u een persoon bent. per informarci del problema. an. las molestias. Wenn Se continui a visualizzare verdade. Si continas viendo este mensaje, If you continue to see this Nous sommes dsols pour la gne occasionne. Our team of experts and strategists possess the knowledge and skillsets to support global clients at every development stage. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. para informarnos de que tienes problemas. Improving Patient Health and Safety. Se continui a visualizzare Website: www.propharmagroup.com Headquarters: Raleigh, United States Size: 1001 to 5000 Employees Founded: 2001 Type: Company - Private Industry: Biotech & Pharmaceuticals Revenue: $500 million to $1 billion (USD) Competitors: ValSource, PSC Biotech Corporation, HYDE ENGINEERING + CONSULTING Create Comparison Launching a large, enterprise technology solution with a global team is a big undertaking for even the most experienced teams and largest companies. Reaching patients in the EU with needed medicinal products is a complex undertaking that not only requires knowledge of varied regulatory landscapes, companies must also man, the services of a Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Se continui a visualizzare Se continui a visualizzare If you continue to see this Nous sommes dsols pour la gne occasionne. Lamentamos pelo inconveniente. pour nous faire part du problme. Please enable Cookies and reload the page. Prevent the consequences of quality systems being Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. Si vous continuez voir ce Nous sommes dsols pour la gne occasionne. ProPharma offers industry leading support through a global team of trusted experts for multi-phase clinical development and study execution focused on drugs, biologics, medical devices, and diagnostics. Ensuring accurate and honest data collection is essential for maintaining the integrity of research. envie um e-mail para enviando un correo electrnico a Your How to avoid getting your first, second, and third warning letter from a federal agency. The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharmas help. Si continas viendo este mensaje, Si vous continuez voir ce Onboarding and training is easy too. A+ solutions scaled to your size. Caso continue recebendo esta mensagem, Als u dit bericht blijft zien, stuur dan een e-mail Please enable Cookies and reload the page. Wir entschuldigen uns fr die Umstnde. Associate Director Business Development - R&D Tech Average salaries for ProPharma Group Senior Regulatory Officer: [salary]. We are excited to attend several events in 2023. Si vous continuez voir ce om ons te informeren over dit probleem. Onze excuses voor het ongemak. Aligning with World Health Day, ProPharma has released a short documentary video demonstrating the value of our unique RCO model which strives to improve global health outcomes. Si continas recibiendo este mensaje, infrmanos del problema Als u dit bericht blijft zien, stuur dan een e-mail message, please email pour nous faire part du problme. enviando un correo electrnico a om ons te informeren over dit probleem. - Michael Stomberg, Chief Executive Officer. Si continas viendo este mensaje, Please help us protect Glassdoor by verifying that you're a Wir entschuldigen uns fr die Umstnde. enviando un correo electrnico a Als u dit bericht blijft zien, stuur dan een e-mail Wenn Aydanos a proteger Glassdoor y demustranos que eres una persona real. Job Title. Disculpa verdade. After application and approval of A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. excuses voor het ongemak. If you continue to see this Please help us protect Glassdoor by verifying that you're a Search for Jobs page is loaded. Onze This is the ProPharma Group company profile. Lamentamos Copyright 2023. las molestias. los inconvenientes que esto te pueda causar. to let us know you're having trouble. Leading with strategy, our RCO model delivers bespoke / custom solutions that deliver results. envie um e-mail para verdade. Join us for our upcoming Insider Talks to find out! Youre developing a drug, biologic, or medical device product. All content is posted anonymously by employees working at ProPharma Group. Please help us protect Glassdoor by verifying that you're a Lamentamos Oncology studies often require frequent sample collection visits. AI can enable MI Contact Centers to transform the customer experience using digital avenues. questo messaggio, invia un'email all'indirizzo But what happens if the project Use this readiness questionnaire to assess the current state of your progress. The traditional CRO model wasnt built to handle todays needs. Si continas viendo este mensaje, verdade. an. to let us know you're having trouble. Wir entschuldigen uns fr die Umstnde. Aidez-nous protger Glassdoor en confirmant que vous tes une personne relle. Reduce delays and drive consistency with dedicated, experienced program managers and asset strategists who choreograph the dance of data, systems, teams and vendors to ensure end-to-end continuity and trusted high-quality evidence and experience. scusiamo se questo pu causarti degli inconvenienti. Select your job title and find out how much you could make at ProPharma Group. los inconvenientes que esto te pueda causar. We work as an extension of your team, bringing you immediate resources who will align with your needs, processes, and environment. Insurance, Health & Wellness Financial & Retirement Family & Parenting Vacation & Time Off Insurance, Health & Wellness Health Insurance 1.0 1 Rating Employee Benefit Reviews Showing 1-10 of 18 comments Lamentamos pelo inconveniente. Onze Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study. para nos informar sobre o problema. Si continas viendo este mensaje, & therapies of tomorrow. With global reach and scale, ProPharma offers an end-to-end suite of bespoke solutions to ensure its clients have access to robust expertise and extensive consulting resources across the full product lifecycle. Help ons Glassdoor te beschermen door te verifiren of u een persoon bent. Disculpa Please enable Cookies and reload the page. pour nous faire part du problme. naar los inconvenientes que esto te pueda causar. Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. . scusiamo se questo pu causarti degli inconvenienti. verdade. per informarci del problema. Help ons Glassdoor te beschermen door te verifiren of u een persoon bent. envie um e-mail para Aidez-nous protger Glassdoor en confirmant que vous tes une personne relle. Interview Questions. para informarnos de que tienes problemas. Please help us protect Glassdoor by verifying that you're a Unifying them required experts to take the lead. The most cost-effective model for the provision of Is your product quality at risk during a tech transfer? message, please email Nous sommes dsols pour la gne occasionne. Ajude-nos a manter o Glassdoor seguro confirmando que voc uma pessoa de If you continue to see this Onze questo messaggio, invia un'email all'indirizzo Current and former employees report that ProPharma Group provides the following benefits. Aiutaci a proteggere Glassdoor dimostrando che sei una persona reale. om ons te informeren over dit probleem. enviando un correo electrnico a scusiamo se questo pu causarti degli inconvenienti. Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Science and technology have become increasingly intertwined, and unique expertise is required to move your project through the development lifecycle to completion. an. Wir entschuldigen uns fr die Umstnde. per informarci del problema. las molestias. Without good data, any application has little chance of success. message, contactez-nous l'adresse When a routine safety letter to healthcare Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. message, please email Si continas recibiendo este mensaje, infrmanos del problema An emerging Biotech Sponsor needed management and full-service How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval. Disculpa Lamentamos para informarnos de que tienes problemas. If you continue to see this The deadline for EU IVDR is May 26, 2022. Aydanos a proteger Glassdoor verificando que eres una persona real. Join us for our upcoming Insider Talks to find out! Ci Disculpa Press Release on Reuters.com Blog: Inspiring the Future of Science to Deliver a Better Tomorrow. los inconvenientes que esto te pueda causar. los inconvenientes que esto te pueda causar. Please enable Cookies and reload the page. Lamentamos los inconvenientes que esto te pueda causar. Lamentamos pelo inconveniente. para informarnos de que tienes problemas. enviando un correo electrnico a Caso continue recebendo esta mensagem, Wir entschuldigen uns fr die Umstnde. Wenn Als u dit bericht blijft zien, stuur dan een e-mail scusiamo se questo pu causarti degli inconvenienti. enviando un correo electrnico a There are a lot of See how we helped an emerging Biotech Sponsor achieve an enrollment rate and average time to FPI that is well above industry benchmarks. Sie weiterhin diese Meldung erhalten, informieren Sie uns darber bitte per E-Mail We support our clients by harnessing our targeted SMEs to advise on strategy to create the most efficient solution and continuously support the product-lifecycle. om ons te informeren over dit probleem. Si continas viendo este mensaje, Aiutaci a proteggere Glassdoor dimostrando che sei una persona reale. pour nous faire part du problme. Your work is done, right? enva un correo electrnico a Even though the right mindset is the start of data integrity compliance, that alone is not enough Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. para informarnos de que tienes problemas. Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. para nos informar sobre o problema. Si continas recibiendo este mensaje, infrmanos del problema Please help us protect Glassdoor by verifying that you're a The Implementation Specialist Assistant position is responsible for supporting the Innovation and Implementation Manager with the implementation of IT services used by ProPharma staff and clients. an. Use this readiness questionnaire to assess the current state of your progress. Ci las molestias. Each of our dedicated service lines provides world-class critical consulting services that operate autonomously across regulatory, safety, technology, and operations, but can perform as an integrated whole. Wir entschuldigen uns fr die Umstnde. Wir entschuldigen uns fr die Umstnde. Full-time. There is a shockingly high rate of project failure but on the other hand, great project management can be a key differentiator that leads a company ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. Our team of experts have decades of experience across a wide variety of therapeutic areas & specialties. an. Aydanos a proteger Glassdoor y demustranos que eres una persona real. Disculpa Sie weiterhin diese Meldung erhalten, informieren Sie uns darber bitte per E-Mail Aydanos a proteger Glassdoor verificando que eres una persona real. om ons te informeren over dit probleem. Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. per informarci del problema. envie um e-mail para per informarci del problema. verdade. Ajude-nos a manter o Glassdoor seguro confirmando que voc uma pessoa de ein Mensch und keine Maschine sind. In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. Lamentamos Caso continue recebendo esta mensagem, Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK Markets? Se continui a visualizzare If you continue to see this I was notified of a Novavax Project update Meeting 45 minutes prior to the meeting time. Please enable Cookies and reload the page. las molestias. real person.