Regulatory Approvals and Compliance

• Global Regulatory Expertise: Proven track record of successful submissions and approvals in major markets including EUGMP, PICS, ANVISA, USFDA, COFEPRIS, and more.
• Pre-Inspection Readiness: Comprehensive gap analysis and remediation to ensure your quality management system (QMS) and documentation are inspection-ready.
• Root Cause Analysis and Corrective Action: Identification of root causes of non-compliance and implementation of effective corrective and preventive actions (CAPA).

Regulatory Submissions and Support

• Marketing Authorization Holder (MAH): Acting as your MAH in designated markets, ensuring regulatory compliance and post-marketing obligations.
• Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV): Providing qualified personnel to oversee batch release and pharmacovigilance activities.
• Batch Release and Testing Sites: Designation of qualified sites for batch release and testing, ensuring product quality and safety.

Regulatory Affairs Expertise

• Dossier Preparation and Review: Meticulous preparation and review of CTD, ACTD, eCTD, DMF, and CEP dossiers for various markets.
• Risk Management Plans (RMP): Development of comprehensive RMPs to identify, assess, and mitigate risks associated with your products.
• Non-Clinical and Clinical Overviews: Preparation of clear and concise overviews of non-clinical and clinical data for regulatory submissions.
• Safety Data Sheets (SDS/MSDS): Drafting and authoring of SDS/MSDS documents in compliance with regulatory requirements.
• Quality Documentation: Development and review of essential pharmaceutical documents like SOPs, Quality Manuals, and Site Master Files (SMF).

Technology Transfer

• R&D Development Support: Assistance with research and development activities, ensuring smooth transition from concept to commercialization.
• Know-How and Dossier Transfer: Seamless transfer of technical know-how and EU-approved dossiers to facilitate market entry.

Pharmacovigilance

• PSUR Preparation and Review: Preparation and review of Periodic Safety Update Reports (PSURs) to monitor the safety of your products.
• PSMF and SOP Development: Development of Pharmacovigilance System Master Files (PSMF) and SOPs to establish robust pharmacovigilance systems.
• Risk Management Plans (RMP): Ongoing review and updates of RMPs to reflect evolving safety information.
• Training and Audits: Comprehensive pharmacovigilance training and auditing programs to maintain compliance and vigilance.

Your Partner in Pharmaceutical Success

Our expertise, dedication, and unwavering focus on regulatory compliance make us the ideal partner to navigate the complexities of the pharmaceutical industry. Contact us today to explore how we can empower your pharmaceutical journey.