USA

Our expertise in expanding your market backed by our experience in the US

USA

The context of the US is marked by a higher freedom in establishing pharmaceutical prices what, together with the existence of some of the biggest pharma companies, continues placing the US as one of the biggest shareholders of the market. Hence, the interest in commercializing in the US is notorious for those clients wishing to boost their possibilities.

Nonetheless, the US counts with a rigid regulatory system headed by the FDA, together with CDER and CBER and the Code of Federal Regulations, among others. For a market strategy to be successful within the US context, a good and detailed understanding on how processes and standards vary, as well as having presence and contact with the regulatory authorities becomes paramount when looking for an expansion from the European market.

Our experience in the US aims at positioning your product in a valuable place to foster approval and commercialization.

USA Solutions

Regulatory consultancy and strategy for all regulatory procedures
- Gap analysis and feasibility assessment
- Regulatory roadmaps
- Preparation and participation in strategic contacts and meetings with the FDA with support from US specialized partner:
  - Preparation of Meeting Request and Meeting Packages, as well as any requested documentation
  - Type A, B and C meetings
  - Pre-IND and EOF2 meetings
  - Management of meeting calendars and answers
Writing of reports: annual reports, feasibility reports and Due diligence, DMF preparation, Gap Analysis of EU dossiers for parallel development EU/US. Assistance in extending commercialization from EU to US
Authorization for new drug commercialization: NDA/ANDA/BLA elaboration and submission. Pre-NDA and Pre-BLA meeting management
Activities for IND maintenance and product maintenance; management of amendments and update of documentation
Medical scientific writing, including CMC, Clinical and Non-clinical information. Assistance and management of publishing activities
Writing and Authoring of all Technical and Scientific Documentation
Submission Management for all Regulatory Procedures
- e-Submission Expert Services including FDA Electronic Gateways
ODD request (elaboration of application and submission)
Elaboration of Pediatric Study Plans (PSP)
Quality Management System (QMS) design and implementation for medical devices based on 21CFR 820
All these procedures are carried out with the support of Asphalion’s US agent, with over 20 years’ experience in the pharmaceutical and biotech industries in the US context

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Why Asphalion?

Asphalion has been working in Regulatory activities with the FDA since 2005 and has established a strategic alliance with Reguliance, a company founded by Bruce Thompson specialized in providing regulatory support and project management to drug and biotech firms.

For the last 3 years, ASPHALION has managed over 70 projects involving the preparation, submission and/or maintenance of different types of applications for US, including Pre-IND meetings, INDs, NDAs, BLAs, ANDAs, DMFs, ODD and PSPs, in direct contact with the FDA.

Main benefits