FDA Regulatory Consulting

Hack & Associates provides consulting services and smart solutions to clients with logistical issues including packaging, labeling, product positioning, and lean manufacturing.  We also focus on risk management and intellectual property valuation.

Hack & Associates provides clients with assistance developing risk management portfolios by mapping out the intellectual property, regulatory, and reimbursement pathways for medical devices intended to come to market.

H&A provides comprehensive cost analysis and risk mitigation plans specifically designed to bring a product concept to the market.

We use our unique expertise to provide companies and investors alike with the appropriate tools to make intelligent and informed decisions in the biotech area.  We understand that the product life cycle, from conception to market, can be long and expensive.  From discovery and development to clinical trial development to reimbursement, the time to investment for a biotech company can extend as far as 7 – 12 years.  Under these circumstances, it is important to manage the expectations of investors and to provide them with real milestones and deliverables that are indicative of both success and progress.

Hack & Associates can help develop regulatory strategies, product launch plans, and development cycles to help manage the growth of small companies as well as the expectations of investors.  Furthermore, H&A identifies and protects any valuable intellectual property that is developed through the product development cycle.  From beginning to market H&A has the tools and knowledge to provide a one-stop-shop experience for small start-up biotech companies and venture capitalists groups looking to support start-up biotech companies.  Hack & Associates can also provide document creation, from licensing agreements and applications for intellectual property to clinical trial agreements, regulatory filings, and standard operating procedures in compliance with current Good Manufacturing Practices (cGMP), current Good Documentation Practices (cGDP), current Good Laboratory Practices (cGLP) and current Good Clinical Practices (cGCP).