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Global Post Approval Solutions

Global Post Approval Solutions

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Our specialized Global Post Approval solutions are designed to ensure your pharmaceutical products maintain compliance and market presence throughout their lifecycle. Leveraging our deep industry knowledge and regulatory expertise, we provide comprehensive support that helps you navigate the complex post approval landscape effectively and efficiently.

Expert Management of Regulatory Obligations

Once a product is approved, the challenge shifts to maintaining compliance with global regulatory standards and managing any post marketing commitments. Our team excels in:

  • Continuous Regulatory Support: Ensuring ongoing compliance with all local and international regulatory requirements to prevent any market access issues.
  • Lifecycle Management: Strategically extending the commercial life of your products through proactive lifecycle management.
  • Change Control Assessments: Conducting thorough regulatory change control assessments to ensure all changes meet current regulatory standards and are documented appropriately.

Tailored Compliance Strategies

We understand that each market has its unique regulatory landscape. Our services are tailored to meet these specific needs, enabling your product to thrive in diverse environments:

  • Customized Submission Strategies: Developing and implementing tailored submission strategies for maintaining product licenses in various markets including the US, EU, Japan, China, and LATAM.
  • Responsive Adaptation to Regulatory Changes: Quickly adapting to regulatory changes and updating submission strategies as necessary to minimize compliance risks.

Documentation and Quality Control

Maintaining a robust documentation process is key to successful post approval management. We assist with:

  • Authoring and Updating Key Documents: Handling all necessary documentation tasks such as authoring Module 3, 2.3, and relevant Module 1 sections for global marketing applications.
  • Quality Checks and Data Integrity: Implementing strict quality control measures including second person reviews to ensure data integrity and compliance in all submissions.

Proactive Market Engagement

Our approach to post approval management also includes proactive strategies to maximize your product’s market potential:

  • Market Surveillance: Monitoring market trends and regulatory updates to keep your products compliant and competitive.
  • Engagement with Regulatory Agencies: Facilitating direct interactions with regulatory agencies to address any issues swiftly and effectively, ensuring that your products continue to meet all necessary standards.

Partnering with Syner-G

For your global post approval needs means gaining a dedicated ally who understands the importance of product longevity and market success. Our expert team is committed to providing the strategic support and operational excellence that your products require post launch. We aim to not only maintain but enhance your product’s market standing through meticulous compliance and innovative lifecycle management. Contact us today to learn how we can assist in sustaining and expanding your product’s success in the post approval phase.