Swiftwater Group’s regulatory services overlap with many of our non-clinical, clinical, QA, and CMC services in our effort to provide integrated drug development services. Regulatory activities are generally complex, but our regulatory experts are fluent in and up-to-date on all regulations and guidance from the FDA, EMA, and ICH. We offer strategic development, regulatory submissions, health agency liaison, and other services that ensure every regulatory nuance is covered.
Global Regulatory Strategy
Regulations are constantly being revised and updated and it is imperative that companies keep abreast of new developments. With the increasing harmonization of regulations and guidance, it is becoming more important to develop an integrated global regulatory strategy to ensure the most efficient use of human, financial, and scheduling resources. Swiftwater Group’s project managers will help to keep the project on schedule through milestone development and team accountability.
Swiftwater Group’s comprehensive knowledge of regulations and guidance in the U.S. and Rest of World allows us to help clients assess a drug candidate, select appropriate indications, and evaluate other contributing factors to help our clients develop the optimal regulatory strategy.
Preparation of Regulatory Submissions
Swiftwater Group works with clients to prepare all regulatory documents required for applications. Our extensive understanding of FDA, EMEA, and ICH requirements ensures submission of clear and reviewable documents that will be clear and reviewable by the regulatory agencies. SWG is expert in using the Common Technical Document (CTD) format, and can provide submissions in either paper or formatted for electronic submission.
Strategic Planning
Target Product Profile
Risk Management Plan
Pediatric Plan
Orphan Drug Designation Request
Package Inserts
Fast Track Designation Request
Applications to Regulatory Authorities
Investigational New Drug (IND) for the US
Clinical Trial Application (CTA) for EU and Canada
Investigational Medical Product Dossier (IMPD) for EU
New Drug Application (NDA) for US
505 (j) - ANDA
505 (b)(1)
505 (b)(2)
Supplemental New Drug Applications (sNDA)
Premarket Approvals (PMA) and 510(k)s
Biological License Applications (BLA)
Marketing Authorization Application (EU)
Other Submissions
Maintenance documents (e.g., annual and informational updates, protocol amendments)
Type I/II Variations (EU)
Drug Master Files (DMF)
Regulatory Operations
As a follow-on service to developing regulatory strategy, Swiftwater Group also provides clients with long-term support to provide the necessary regulatory expertise throughout the product development process.
Sponsor Representative and Meeting Preparation
Swiftwater Group has extensive experience working closely with the US FDA to gain approval for new medications and can represent the client’s interests to the Agency. Our staff can serve as FDA liaison for companies based in the US or as the US Agent Representative for non-US companies.
Swiftwater Group works with the sponsor company to prepare for meetings (e.g., Pre-IND, End-of-Phase 2, Scientific Advice Requests, Protocol Assistance requests, Pre-NDA), receive official documentation, draft formal communications, and attend advisory meetings (e.g., labeling, pediatric, CMC). In addition, we can:
Prepare meeting request s in a manner to achieve desired FDA interaction
Determine meeting strategy
Draft and prepare briefing packages
Predict likely issues and identify "what if" scenarios
Conduct practice sessions for meetings
Attend meetings and represent client interests
Prepare sponsor meeting minutes
Due Diligence Analysis
Swiftwater Group uses its analytical skills and broad drug development experience to value a product, portfolio, or company. Business Development professionals and industry investors hire Swiftwater Group to provide objective opportunity assessment to support licensing, funding, and divestiture decisions. We can assess a product’s or company’s merit across a number of areas, including:
Overall integrated development process for a drug or platform technology
Critique of design or results of non-clinical and clinical studies
Assessment of regulatory strategy, regulatory submissions and communication
