Regulatory Consulting Services

Regulatory Strategy

Regulatory Strategic consulting to enable faster to market pathway.

Author Regulatory Documents

Act as FDA agent and keep your company compliant with all FDA regulations.

Submit IND/NDA/BLA/ 510K and supplemental applications in eCTD format to US FDA.

File clinical trials under EU CTR and provide guidance on marketing application submission in EU, UK and Switzerland.

Author Clinical Modules for CTD

Clinical Study Reports

Development Safety Reports

Regulatory Submissions

Medical Writing