Pharmacovigilance Services

Pharmacovigilance Services

At Mxpress, we understand the critical role pharmacovigilance plays in ensuring the safety and efficacy of pharmaceutical and biotechnology products. Our comprehensive range of pharmacovigilance services is tailored to meet the unique needs and regulatory requirements of your industry. Here's an overview of the pharmacovigilance services offered by Mxpress:

Regulatory Strategy Development

Craft comprehensive regulatory strategies aligned with your overall business objectives, guiding product development and facilitating successful market entry

Preclinical and Clinical Trial Regulatory Support

Assist with regulatory submissions for preclinical and clinical trials, including IND applications and NDAs, ensuring adherence to regulatory standards. 

Regulatory Intelligence and Monitoring

Keep you informed about evolving regulatory requirements, providing timely intelligence on changes that may impact your product development and registration. 

FDA Interactions and Meetings

Prepare for and facilitate interactions with regulatory authorities, such as the U.S. FDA, including pre-submission meetings and regulatory consultations. 

EMA and Global Regulatory Submissions

Support regulatory submissions to the European Medicines Agency and other global regulatory bodies for international market approvals. 

Orphan Drug Designation Assistance

Provide guidance and support in obtaining orphan drug designation, including the preparation and submission of orphan drug applications. 

Fast Track, Breakthrough Therapy, and Priority Review Designation Support

Assist in applications for special designations to expedite regulatory review processes for products addressing unmet medical needs. 

Regulatory Compliance Audits

Conduct audits to ensure adherence to regulatory requirements, GCP, GLP, and GMP, identifying areas for improvement and ensuring compliance. 

Regulatory Due Diligence

Conduct thorough assessments of regulatory compliance during mergers, acquisitions, or partnerships, identifying potential risks and liabilities. 

Post-Market Regulatory Services

Provide support for post-marketing surveillance, adverse event reporting, and compliance with post-approval regulatory requirements

Regulatory Writing Services

Prepare and review regulatory documents, including clinical study reports, investigator brochures, and regulatory submissions

Quality Management System (QMS) Implementation

Assist in the development and implementation of QMS to ensure compliance with regulatory requirements. 

Regulatory Training Programs

Conduct training programs to educate your teams on regulatory compliance, changes in regulations, and best practices. 

Product Labeling and Advertising Review

Review and ensure compliance of product labeling, packaging, and advertising materials with regulatory requirements. 

Regulatory Risk Assessment

Evaluate potential regulatory risks and provide strategies for risk mitigation, ensuring proactive risk management. 

Biosafety and Biosecurity Compliance

Ensure compliance with biosafety and biosecurity regulations, especially for biotechnology products and gene therapies

Health Authority Inspections Support

Prepare for and support your company during health authority inspections, addressing regulatory concerns and ensuring a smooth inspection process

Compliance with Data Protection and Privacy Regulations

Advise on and ensure compliance with data protection and privacy regulations, particularly in the context of clinical trials and patient data

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