EUROPEAN CLIENT: IND FILINGS, US AGENT

A European start-up company working in oncology was interested in having their first Phase I clinical study in the US. Reguliance assisted the company in understanding the IND format and requirements and reviewed the draft and final IND sections. Reguliance is the US Agent for the IND and one of our European alliance partners, Asphalion, supports the client by submitting the eCTD-compliant IND submissions. The client subsequently completed a licensing deal for the project with a multinational firm. Reguliance and Asphalion work together seamlessly with the client and their licensing partner on the IND filings.

No longer a start-up, this client has filed an IND for a 2nd oncology project for which Reguliance is their US Agent with Asphalion managing the eCTD-compliant IND submissions.

European Client: Orphan Drug Designations, Drug Master Files, pre-IND meetings, IND filings, US Agent

A European spin-off company had two development products involving gene therapy and a fusion protein.  As the registered US Agent, Reguliance worked with the client to file Orphan Drug Designation requests for three indications for one product and one indication for the second product.  Three of the four designations were granted.

Reguliance was contracted to assist in preparing a US regulatory strategy for two indications in conjunction with one of our European alliance partners, Regulatory Pharma Net.  We assisted the client and its original US development partner in preparing and filing an IND for phase I/II clinical work. This sub-project also included assisting in the preparation and filing of four Master Files (two Type II and two Type V) with the FDA Center for Biologics Evaluation and Research (CBER).  Reguliance continues to be the appointed US Agent for these Master Files.

Reguliance was tasked with setting up pre-IND meetings with the FDA for both products in two indications, one involving the FDA Center for Drug Evaluation and Research (CDER) and the other involving the Center for Biologics Evaluation and Research (CBER).  Reguliance worked with the client to prepare the meeting requests and briefing packages, prep for the meetings, address the pre-meeting comments from FDA, and act as facilitator during the meetings on behalf of the client.  Reguliance worked with the FDA to establish the meeting dates, FDA attendees, briefing package submissions, and final meeting minutes.

Reguliance assisted the client in preparing and submitting two INDs in support of their Phase III clinical programs and continues to be the appointed US Agent for both applications.

Investment firm: Due diligence, Pharma startup company, Regulatory management

Reguliance was contracted by a US investment firm to perform regulatory due diligence on a commercial product in ares of US regulatory compliance, CMC compliance, and subsequently to propose strategy and options for issue resolution.

In the second phase of the project, Reguliance collaborated with a small consulting team to assist the client in establishing a virtual pharma startup company. The objective was to bring the commercial product in-house, resolve regulatory and CMC compliance issues, and re-launch the product.

Reguliance acted as the regulatory department for the start-up company and performed regulatory activities, which included:

• Transfer of the NDA and regulatory files
• Revision of the product labeling to reflect the new company and working with the label and packaging companies to ensure timely product packaging.
• Establishment Registration and Drug Product listing
• Setup and management of the pharmacovigilance function
• Setup and management of on-going and new stability programs including oversight of the analytical methods and contract analytical laboratory
• Preparing selected company SOPs and reviewing all company SOPs
• Preparing and filing supplements and routine reporting to the NDA file
• Providing input on regulatory compliance and CMC issues