FDA Premarket Services

Hack & Associates provides the consulting services necessary for companies to navigate the entire product life cycle.  We understand the complexities of regulatory compliance and can help develop strategic portfolios that result in a faster time to market as well as a more robust pipeline.  H&A assists companies with corporate organization, protection of intellectual property, financial structuring, regulatory strategy, product prioritization, market selection, and risk assessment and management matters throughout the product life cycle.

H&A also provides clients with a full range of pre-market and post-market services and strategies. We specialize in bringing products to market for which there are no clearly established regulatory pathways including:

  • Medical Devices (510(k), PMA, IDE’s, HDE, etc.)
  • Pharmaceuticals (NDA, ANDA, IND, Orphan Drugs)
  • Biologics (IND, BLA, Orphan Drug)
  • Combination Products
  • Drug/Device Products
  • Biologic/Device Products
  • Dietary Supplements

H&A provides a wide range of services for clients looking to develop and market regulated products in the United States and in Europe.  H&A develops unique solutions to clients who develop new technologies regulated by the FDA, EMEA or Health Canada.

We enable our clients to obtain market approval and market clearance, comply with post-market requirements, and protect themselves from FDA enforcement actions.  H&A also specializes in mergers, contracts, acquisitions, negotiations, risk assessment, and intellectual property matters related to FDA- regulated products.

We prepare regulatory filings to support new drugs, medical devices, and biologics.