Pre IND – IND
Plan, rehearse, attend, and represent a client for a pre-IND meeting for 505(b)(2) submission. We guided a literature search, researched FDA precedents, developed a research plan and pre-IND briefing document for a virtual company that had a new indication for an old drug. After meeting with FDA our client was able to secure funding for the research required by FDA.
RANA worked with an innovator of a novel nucleotide, directing development of IND complex CMC section and massive pharmacology information. The IND was accepted by FDA. The innovator company was able to raise additional funding based on the milestone of a successful IND filing.
RANA provides ad hoc research and strategic advisory services for consortium members as well as clients.
RANA reviewed a large volume of published literature for a develop GAP-analysis, advising on research data needed for 505(b)(2) for new clinical use. The outcome was the client had a clear understanding of what would be needed from a development partner.
RANA supported the response procedure during an NDA review. In response to a query from FDA on an inactive ingredient for a repurposed drug, RANA advised on strategy, researched options, prepared an opinion paper on technical requirements and drafted the FDA response letter.
RANA published and filed INDs, including amendments, for a European client. The outcome was U.S. regulatory files remained current with a U.S. presence and European research program.
RANA electronically filed two establishment registrations and 43 product listings for a Canadian Client when new FDA regulations took effect. The product was successfully imported into the U.S. within a few weeks.
RANA filed an electronic DMF in eCTD format through the FDA electronic submissions gateway (ESG). The client was pleased to have up to date information available for FDA review.
RANA was the regulatory affairs team member on a major U.S. pharma project team developing a supplemental new drug (SNDA) for a new indication. We structured the integrated summary of safety. As a result, the client received product approval for a new indication.
RANA developed and filed orphan drug applications for a European client, gaining advantages of Agency advice, investor recognition, and efficient product development.
Combination Product – From an investigator-initiated IND for a novel drug delivery system, RANA assembled a team of experts to develop a unprecedented regulatory strategy to accommodate the innovator’s view. The team directed preparations for, prepared briefing documents for, and led the pre-IND meeting. FDA internal product jurisdictional issues emerged, so the RANA team:
- Revised the strategy to one that was acceptable to the innovator and FDA
- Implemented a toxicology program
- Initiated Good Manufacturing Practices (GMP) management system
- Identified and recommended a CRO
- Negotiated with FDA and
- Brought the product to its first commercial clinical trial
RANA directed strategy and dossier development for a pre-IND meeting, and led both the FDA meeting and the post-action meeting. We worked with the client and development partners to develop nonclinical safety information in support of 505(b)(2) new drug application (NDA).
RANA advised a European client on a nucleotide product used as a stent coating, prepared briefing materials, organized and led a pre-IDE meeting and a post-action conference. Thus, the client was provided with the information necessary to seek a development partner
Authorized Representative/US Agent
RANA was asked to help a European client with a US marketing partner resolve importation issues. With our guidance, the product successfully reached the US market.
RANA worked with a Canadian client, which included reviewing, commenting, advising and filing an IND. We advised on FDA strategy and filed amendments including IND safety reports.
RANA registered an establishment for a new owner and listed its products. The client was authorized to continue selling the product in the US.
RANA worked with a manufacturer to develop a drug master file (DMF) required by their customers. We filed and maintained the DMF.
Drug Master File
One of our clients, a supplier of components to the pharmaceutical industry, required a Drug Master File (DMF). Working closely with the client we developed a strategy, assembled the data, wrote the master file, and represented our client’s interests to the FDA. The industry accepted the client’s product and the client enjoyed a measurable increase in sales. A decade later, RANA updated and converted the Drug Master file to eCTD format and re-filed it electronically.
RANA published and filed 23 type II paper DMFs for a Chinese client of a GMP consultant in our consortium. Under a tight time constraint, we completed the volumes, packaged and shipped them to FDA prior to the required deadline.
RANA advised a European client and its U.S. CRO on U.S. regulatory requirements for a gene therapy product. RANA did the following for the client:
- Directed the development of dossiers and presentations to both FDA and NIH.
- Organized meetings and post-action conferences with both FDA and NIH
- Directed dossier development
- Filed IND, amendments, and IND safety reports
When an event in an unrelated gene therapy trial placed the IND on clinical hold, RANA advised the client to conduct the study in a more favorable regulatory climate in Europe.
The end result was the clinical trial was initiated and completed in Europe within six months.