Regulatory Consulting Services for clinical trials

Streamline drug approvals. Navigate guidelines.

PharmaNet/i3 Consulting answers questions regarding regulatory channels to help clients achieve the most efficient path to market for new drugs and biological products. Clients avoid frustrating and costly delays by relying on PharmaNet/i3’s experts for pre-submission quality reviews to ensure completeness, adequate strategic approach, scientific accuracy, and ease of agency review. With regional offices in Asia Pacific, Canada, Europe, Latin America, and the United States, PharmaNet/i3 helps clients adhere to the complex array of regulatory requirements in all the major regions of the world where clinical research is taking place.

A well-designed regulatory submission meets the information needs of all relevant stakeholders. PharmaNet/i3 professionals can assist you in devising a strategy to collect the data needed to support your endpoints, while enabling you to meet both your business objectives and your obligation to the safety of study participants.

Services include:

• Review, preparation and submission of Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) and supplements, Investigational Medicinal Product Dossier (IMPD) and CTA submissions
• Gap analyses of existing data
• Marketing Authorization Applications (MAA)
• Supplements/variations and renewals
• Reformatting of dossiers
• Pediatric Investigational Plan (PIP)
• Observational studies
• Orphan Drug Application (ODA)
• Electronic publication of regulatory submissions, including marketing applications, INDs and CTAs produced in eCTD format
• Automation of quality control procedures
• Facilitation of the review process