As we continue to monitor the rapidly evolving situation around COVID-19, our first thought is for the safety and well-being of all individuals and businesses impacted by these challenging circumstances. We know firsthand the challenges and business risks this health emergency can create. Our global team at ProPharma Group is fully mobilized and working remotely to help you overcome the challenges your team may be facing while responding to new business requirements prompted by COVID-19.
Acting as an extension of your team, our experienced professionals can support your business needs while managing peak workloads in an efficient and compliant manner, ensuring the highest standards of quality for patient health and safety. We are here to support you throughout your product’s lifecycle from early-stage concept development and clinical trials to marketing authorization and post-approval requirements.
Regulatory Affairs: Our experience, expertise, and dedication guide you through the scientific and regulatory requirements across all phases of a product’s lifecycle.
- FDA and EMA Regulatory Assistance: we provide support for all submissions and agency meetings ensuring our clients meet required filing deadlines. For updates on how FDA is responding to COVID-19, click here. For EU Health Authorities’ information, click here.
- Scientific Consulting: we have PhD level consultants representing necessary disciplines such as pre-clinical/toxicology; medical/clinical/drug safety; CMC/manufacturing; biopharmaceutics/pharmacology and medical device technical support.
- Novel Coronavirus Support: for firms preparing solutions for the novel coronavirus, we can help prepare emergency petitions for INDs, expedite submissions for new indications and apply for emergency use for drugs already in trials.
Life Science Consulting: Our highly trained team of experts can seamlessly integrate with your organization to help you with any product development challenge ensuring quality and regulatory requirements are met throughout the entire product lifecycle.
- Technology Transfer: we can quickly and efficiently transfer technology from a single site to multiple.
- Program and Project Management Support: we are remotely enabled and available to lead projects right away. Global team skilled in current PM techniques and processes.
- CMO Selection: our database and processes can identify global vaccine manufacturers, capacity, and capabilities.
- Novel Coronavirus Support: for firms preparing solutions for the novel coronavirus, we can help with product development (CMC), analytical methods, facility, and process design, clinical trials, scale-up of production to a commercial scale and process validation as well as Quality Assurance and QP release.
- Remote GDP and GMP Audits: we have pre-defined and robust remote audit processes in place to support you. We conduct audits remotely in a thorough manner enabling compliance with your audit requirements.
Pharmacovigilance: Our comprehensive suite of PV services supports you in ensuring all your PV tasks are performed in an efficient and compliant way to uphold the highest quality for patient health and safety.
- Direct PV Support: our global team of experienced clinical PV professionals can provide direct support of your development efforts.
- Secondary PV Support: we can augment your team and provide support of your routine post-marketing PV activities to free up your resources for more valued tasks.
- On-site or Remote Support: we can quickly support during peak workloads with our trained team of data entry specialists, medical experts in multiple therapeutic areas, medical writers, auditors, and more.
- Remote GCP and GVP Audits: we have pre-defined and robust remote audit processes in place to support you. We conduct audits remotely in a thorough manner enabling compliance with your audit requirements.
Medical Information: Our 8 global contact centers respond to Medical Information Inquiries, Adverse Event and Product Quality reports in more than 30 languages from patients and healthcare professionals around the world. With a customer and patient-centric approach to service delivery, our flexible options and adaptable resources can support you as your business needs scale up or down.
- Expanded Coverage Support: we can supplement hours of operation and bandwidth of your MI team with dedicated support to handle increased inquiry volumes for both in-hours and out-of-hours service.
- Global Service Alignment: whether you have a regional service or a global MI service, our aligned processes and global support implementation of “follow the sun” inquiry management model, leveraging global capabilities in USA, Europe, Australia, and Japan can cover your MI needs.
- Enhanced Inquiry Support: expand the power of our MI teams to handle more than just your MI, AE, and PC volume. Our highly trained teams can triage and respond to your customers’ critical and timely inquiries regarding this pandemic with information they need to know regarding your products or re-direct to the appropriate department within your company.
We are ready to assist you as this pandemic unfolds. Please let us know how we can help you as your business requirements evolve.