Regulatory Strategy & Services

Within PharmaLex, we strive to become your partner, and not just another vendor. Take advantage of our years of experience in the pharmaceutical field, encompassing numerous negotiations with many FDA Offices and review Divisions. Our experts are knowledgeable and up-to-date on regulatory guidances from the FDA, EMEA, ICH and most markets.  We have a proven track record of successful regulatory planning processes, which highlights the quality and mutual trust behind the close working relationships we strive for with the FDA. We collaborate with you to advocate for your company, your ideas, and your products to the FDA.

You can rely on the professional experience and support of our experts all along the line – from the conception of the pre-IND development plan right down to approval and launch. The development strategies we design are based on the scientific data known today and the anticipated developments in the regulatory environment of tomorrow. Together we can prepare a development and submission strategy that is custom designed for you and your product.

Whether you are looking to in-license or out-license, we can represent your interests in the preparation and performance of Due Diligence processes. We perform a critical assessment of Agency communications, regulatory submissions, and therapeutic area requirements and will provide clear recommendations for informed decision-making.

Our regulatory strategy services include:

  • Regulatory FDA strategic planning from pre-IND through Post-Marketing
  • FDA meeting preparation and conduct
  • IND, NDA, BLA, ANDA, etc. guidance
  • Accelerated approval pathways
  • Pediatric development
  • Drug/Device combinations
  • Orphan Drug designation
  • Due Diligence support
  • Comprehensive expert support for Biosimilars
  • Advertising and Promotion Review