Regulatory Submissions
We use a collaborative approach which integrates diverse scientific information to create a complete and successful regulatory submission. We have prepared, submitted and maintain more than 85 INDs and CTAs and ably assist our clients in responding to regulatory agency inquiries in a timely and effective fashion.
We use a collaborative approach which integrates diverse scientific information to create a complete and successful regulatory submission. We have prepared, submitted and maintain more than 85 INDs and CTAs and ably assist our clients in responding to regulatory agency inquiries in a timely and effective fashion.
Many final clinical protocols are first critiqued by our team of scientists and consultants, streamlining the regulatory acceptance process and thereby advancing the timeline of study initiation. In addition, we have generated or provided editorial review of Investigator’s Brochures on a variety of drugs and drug candidates.