Develop practical regulatory strategies that support product development, approvals, and compliance across global markets.
Support marketing authorization applications with complete documentation and regulatory submission planning.
Identify regulatory gaps, address compliance issues, and implement corrective actions before inspections or submissions.
Assess regulatory risks, compliance status, and documentation to support licensing, acquisitions, and investments.
Prepare and maintain API and DMF documentation while supporting regulatory compliance throughout the product lifecycle.
Provide regulatory guidance for Chemistry, Manufacturing, and Controls documentation to support product approvals.
Assist with ANDA submissions, maintenance, and Market Authorization Holder regulatory responsibilities and compliance.
Prepare, validate, publish, and submit eCTD dossiers that meet global health authority technical requirements.
Develop and maintain compliant product labeling aligned with regional regulations and approved product information.
We used Atvigilx’s safety monitoring service and I appreciate their thoroughness. Their team delivered in adverse event assessment and complaint handling. With on time support we successfully tightened our safety processes. Thank you for dependable service.
-Head of Safety & Compliance, Bulgaria
I engaged Atvigilx for clinical safety support and I appreciate their team. Their expertise in SAE reporting and protocol safety assessments was evident. We successfully met IRB and sponsor timelines because of prompt, on time support. Thank you for excellent service.
-Clinical Safety Coordinator, USA
I appreciate the team’s expertise in aggregate reports and CAPA management. With consistent on time support, we successfully passed regulatory inspections. Thank you, their service strengthened our PV system.
-PV Program Manager, India
We partnered with Atvigilx for pharmacovigilance services. I appreciate their team and expertise in case processing. We successfully met tight deadlines thanks to support and clear communication. Thank you, the service boosted our compliance confidence.
-Head of Pharmacovigilance, USA
As QA manager, I praise Atvigilx’s PV service. Their team showed expertise in signal detection and aggregate reporting. We successfully improved our safety timelines with support and proactive recommendations. I appreciate their responsiveness, thank you.
-QA Manager, Thailand
We engaged Atvigilx for device vigilance services and I appreciate the team’s pragmatic approach. Their expertise in regulatory submissions and on time support helped us close audit findings. We successfully maintained market access. Thank you for reliable service.
-Regulatory Affairs Lead, Poland
I recommend Atvigilx for pharmacovigilance operations. Their team brought strong expertise to ICSRs and quality systems. We successfully transitioned our PV processes with minimal disruption, supported by on time support and clear training. I appreciate their dedication.
-Safety Operations Director, Australia
Atvigilx specializes in Pharmacovigilance, Regulatory Affairs, and GCP Services, providing comprehensive support to ensure compliance…