PLG supports U.S.-based biopharma companies as an integrated pharmacovigilance and regulatory partner for EMA and MHRA regulatory affairs.
ProductLife Group leverages more than 30 years of experience in the European market to offer ongoing expertise as an integrated partner for U.S-based biopharmaceutical companies seeking to enter Europe. Our team offers pharmacovigilance and regulatory strategy and services for diverse therapies, molecules (novel small molecules, generics, biologics, biosimilars), and devices.
Pharmacovigilance is integral to a sound regulatory strategy for entering European market. Biopharmaceutical companies must establish a continuous pharmacovigilance setup as part of their regulatory plan when approaching the European Medicines Agency (EMA) and/or United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) for marketing approval.
Helping you prepare for submission to EMA and MHRA through pharmacovigilance setup for clinical and post-marketing pharmacovigilance:
- Appoint the Responsible Person (RP), EudraVigilance registration and setup
- Appoint the EU Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV) to manage the medicinal product portfolio in the European Union
- Author and manage the Pharmacovigilance System Master File (PSMF) for product authorization in the EU
- Post-marketing pharmacovigilance support
Advancing with regulatory strategy and regulatory affairs with EMA and MHRA
- Pharmaceutical product development consulting and advisory services
- Medicinal products and medical device regulatory registration strategy
- Health authority Interactions - EMA, MHRA, and other national competent authorities
- Clinical trial applications authoring and management
- Orphan drug designations
- Pediatric investigation plans
- Marketing authorization application (MAA), dossier preparation, clinical and non-clinical authoring
- Dossier gap analysis and adapting new drug applications (NDAs) to MAAs
- Health authority query responses and negotiation
- Post-approval maintenance and lifecycle management
- eCTD publishing and submissions management
- Country-level support with local presence in all EU countries
Centralized Project Management
ProductLife Group's project management maturity is driven by established processes, key performance indicators, and metrics to aid our clients' success in the EU and UK. Our processes are derived from decades of experience that our expert consultants have gained from working with health authorities to obtain approval for numerous products, coupled with PLG's operational excellence in managing pharmacovigilance and regulatory projects.
Our U.S.-based clients range from small biotechnology to large pharmaceutical companies, who benefit from continuous attention to their needs. Our team is passionate about supporting the product lifecycle of our clients' life-saving and life-changing products and we take care of your projects as though they were our own.
Get in touch
Talk with our experts today to explore your EU and UK strategy for product development, commercialization, and lifecycle management.