Effective use of resources is key to efficient drug development. Having been in the industry since 1990, Sandy’s experience and network facilitate quick identification of resources a client may need, beyond those Hecker & Associates can provide directly.

Sandy’s experience managing regulatory submission contractors at Genentech, and managing submission writing regulatory groups at four (thanks to mergers) Contract Research Organizations (CROs) enabled her to identify best practices she uses now to support Hecker & Associates’ clients most effectively. These include:

-Keeping up to date on US regulatory requirements—regulations and guidelines, as well as the unwritten expectations of FDA, based on her experience or that of her colleagues in her professional society networks. (Anyone can read regulations and guidelines, but only those experienced working with them know the various levels at which they apply, in the view of the regulatory authorities.)

-Integrating herself (and any other project expertise needed) so well into the client team, the client understands that Sandy cares as much about the success of the client’s project(s), as the client, which facilitates effective project communication.

-Anticipating potential regulatory issues, and alerting a client to them, before they become too large to resolve easily.

-Ensuring the ability to handle unexpected expansion of a project’s scope, without delaying the project.

-Maintaining professional society networks of expertise to discuss best practices based on recent experience for handling any eventuality, from changing requirements for safety reporting in clinical trials to meeting myriad clinical trial disclosure requirements, to ensure efficient global work.

-Her close proximity to FDA enables Sandy to attend FDA public meetings and FDA Advisory Committee meetings for information to benefit her clients. Her proximity to FDA also facilitates planning for client FDA meetings (e.g., recommended hotels and restaurants).

Hecker & Associates resources include partners in Europe, the UK, Canada, and Australia who can expertly guide clients through biopharmaceutical regulatory and/or writing processes in those regions, while Hecker & Associates maintains current, “real world” information to file appropriate regulatory submissions to FDA to ensure the fastest and best possible regulatory response.

Food and Drug Administration http://www.fda.gov/ US Government Printing Office (GPO), Code of Federal Regulations (CFR) www.ecfr.gov

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) www.ich.org