REGULATORY APPLICATIONS REVIEW SUPPORT

QualiCulture offers expert regulatory support and consulting services to all sizes of pharmaceutical and biotech companies to interpret or navigate the intricacies of pharmaceutical and biotechnology regulations.

We provide regulatory strategies, based on your corporate objectives, for product development, FDA approval pathways, or lifecycle management of marketed pharmaceuticals and biologics.

We also support the review of regulatory documentation. It includes the protocol-based review and assessment of regulatory applications (DMF / NDA /ANDA) for their accuracy and completeness. We provide expert services that evaluate the potential effects of data inaccuracies on submitted applications (Approved and Pending Approval) with regulatory agencies.