Regulatory – US

Pacific-Link Consulting is able to provide a wide range of services to facilitate the registration of medicinal products in the US with our expert regulatory staff and throughout Europe with our EU partner, including but not limited to:

• Cost-effective regulatory strategy development and consultation
• Medical and technical writing for submissions
• Preparation of eCTD applications for submission to US Agencies
• IND, NDA, ANDA, MAA, IMPD preparation and electronic submission in-house
• US Agencies meeting packages – preparation and conduct
• US Agencies representation and direct negotiation services (US Legal Representation Services)
• Serve as a company’s Regulatory Affairs department
• Supplement a company’s Reg Affairs department
• Utilize Acuta software in-house for cost-effective electronic submissions to US health agencies
• Annual Report preparation and filing
• Safety monitoring and reporting (SAE reporting, PSURs)
• Prepare Fast Track Designation Applications
• Submit Fast Track Designation Applications
• Prepare Breakthrough Designation Applications
• Submit Breakthrough Designation Applications
• Prepare Orphan Drug Designation Applications
• Submit Orphan Drug Designation Applications
• Manage Annual Product Listings
• Manage Structured Product Labeling (SPL) conversions
• Manage Drug Establishment Registrations
• Assist with writing Grants

We also perform regulatory services for medicinal products being considered for the Japanese market.