Regulatory Affairs
Regulatory Affairs
Regulatory Affairs
End-to-end regulatory support across the full product lifecycle
End-to-end regulatory support across the full product lifecycle
End-to-end regulatory support across the full product lifecycle
Navigating the global regulatory landscape is complex, time-consuming, and costly. With 80% of new device and drug approvals delayed due to regulatory issues, the right strategic partner can save 6–12 months in approval timelines. We support businesses at every level — Director, Manager, Specialist, and Associate.
Navigating the global regulatory landscape is complex, time-consuming, and costly. With 80% of new device and drug approvals delayed due to regulatory issues, the right strategic partner can save 6–12 months in approval timelines. We support businesses at every level — Director, Manager, Specialist, and Associate.
Navigating the global regulatory landscape is complex, time-consuming, and costly. With 80% of new device and drug approvals delayed due to regulatory issues, the right strategic partner can save 6–12 months in approval timelines. We support businesses at every level — Director, Manager, Specialist, and Associate.
Regulatory Strategy Development: tailored strategies aligned to products, markets, and timelines — the least-burdensome, fastest pathway to approval.
Regulatory Gap Analysis: evaluation of documentation, processes, and compliance posture — identifying gaps before they become barriers.
MDR & IVDR Transition Support: MDD→MDR (EU 2017/745) and IVDD→IVDR (EU 2017/746) transition, technical documentation, clinical evaluations, and QMS.
US FDA Medical Device Consulting: pre-submission meetings, 510(k), PMA, De-Novo, IDE, NDA, BLA, ANDA, and 21 CFR compliance.
UK MHRA & EMA Consulting: MHRA compliance (UKCA marking) and EMA support for EU pharmaceutical and device submissions.
Post-Market Surveillance & Pharmacovigilance: adverse event reporting, PSURs, PMCF planning, and regulatory communications.
Remediation & CER Writing: deficiency remediation, non-conformity resolution, CAPA plans, and expert CER writing (MEDDEV, MDR/IVDR).
Regulatory Strategy Development: tailored strategies aligned to products, markets, and timelines — the least-burdensome, fastest pathway to approval.
Regulatory Gap Analysis: evaluation of documentation, processes, and compliance posture — identifying gaps before they become barriers.
MDR & IVDR Transition Support: MDD→MDR (EU 2017/745) and IVDD→IVDR (EU 2017/746) transition, technical documentation, clinical evaluations, and QMS.
US FDA Medical Device Consulting: pre-submission meetings, 510(k), PMA, De-Novo, IDE, NDA, BLA, ANDA, and 21 CFR compliance.
UK MHRA & EMA Consulting: MHRA compliance (UKCA marking) and EMA support for EU pharmaceutical and device submissions.
Post-Market Surveillance & Pharmacovigilance: adverse event reporting, PSURs, PMCF planning, and regulatory communications.
Remediation & CER Writing: deficiency remediation, non-conformity resolution, CAPA plans, and expert CER writing (MEDDEV, MDR/IVDR).
Why choose PBC-UK?
• 15+ years of combined regulatory experience
• 15+ years of combined regulatory experience
• Direct FDA, MHRA & EMA expertise
• Direct FDA, MHRA & EMA expertise
• Proven, least-burdensome pathways
• Proven, least-burdensome pathways