Mikart’s pharmaceutical regulatory support team offers a full range of regulatory support, from completing your entire FDA e-submission to a la carte services customized to your project’s specific demands. Regulatory staff are integrated into the R&D group to assure that the regulatory aspects are addressed throughout analytical development.
Our proactive regulatory experts work tirelessly to position your project ahead of current standards and DSCSA requirements; for example, we have offered pharmaceutical serialization (which will not be mandatory until 2023) since 2015. Read more about how and why Mikart chose to be a future-ready CDMO for clients of all sizes — from small and virtual companies to large organizations — in our blog.
Services Offered
| Application compilation and submission in e-CTD format |
| Application maintenance and life cycle support |
| Authorized U.S. agent |
| Labeling support |
| Regulatory support for interactions with governing agencies |