The regulatory journey doesn’t end at product approval. And neither does our partnership.
Even after your product earns regulatory approval, the compliance journey continues. Particularly for mid-size and large manufacturers that have multiple products on the market, it can be costly and inefficient to hire full-time staff to manage regulatory filings throughout the pharmaceutical product lifecycle.
Our dedicated FTE models provide a more cost-efficient, cost-effective, scalable solution. Our regulatory consulting and medical writing experts work as an extension of your team, managing all of your post-approval regulatory filings. So you can stay in compliance, without the overhead costs.
Our team of pharmaceutical lifecycle management consultants can
- Work independently or under the direction of a member of your management team
- Help to establish your regulatory strategy for maintaining consistent submissions
- Interact with your manufacturing group(s) to evaluate deviations and change controls for global regulatory impact
- Develop submission-ready documents, prepared according to your specific internal requirements – or prepared using one of our established templates
And, our partner-based, milestone-driven business model for pharma lifecycle management is highly flexible, allowing it to be easily customized to your specific needs.
Find out how we can help you
Find out how our FTE models can keep you in compliance, while reducing your costs. Contact us today.