Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

medical

Regulatory Operations

The FDA is requiring the pharmaceutical and biotech industry to transition from a paper-based system to the electronic Common Technical Document (eCTD) format for regulatory submissions.  Electronic submissions will likely be mandatory for all NDA submissions by 2015 and for all IND submissions by 2016.

IMPACT has the capability and experience to format, compile, publish, and submit all of your required regulatory documents via FDA’s Electronic Submissions Gateway (ESG).

Extensive Experience

IMPACT’s Regulatory Operations staff has the extensive training and experience needed to manage and execute each step of the electronic submissions process.  We have a full set of standard operating procedures in place to ensure each electronic submission we make is of the highest quality, and we use a validated, 21 CFR Part 11 compliant electronic document management system to archive all regulatory submission documents.

Our publishers have collectively worked on more than 40 INDs, either publishing the initial application or managing the lifecycle submissions, as well as several NDAs that were successfully filed with the US FDA. We also have extensive experience compiling and publishing clinical study reports that are either submitted by IMPACT or are ready for our clients to submit to the regulatory authorities.

IMPACT’s Regulatory Operations group stays current in the field of electronic submission by attending local and national seminars and conferences.  Two of our team members were the co-founders of the Electronic Concepts Technical Discussion (ECTD) Group – a local professional organization created in 2009 with a current membership of 80 people.

Services Offered

IMPACT can provide formatting and pre-publication services to ensure your documents and reports are submission-ready with the necessary bookmarks and hyperlinks for inclusion in an eCTD submission.

Using commercially-available publishing software that is widely recognized within the industry and across Regulatory Agencies (including the FDA), we can publish and electronically submit your IND or NDA/BLA and subsequently manage the lifecycle for either of these types of applications.

IMPACT will tailor these offerings to your specific needs, whether you are a small company requiring management of all of your electronic regulatory submission needs or a large company requiring assistance with a single submission.  Regardless of your individual needs, our Regulatory Operations staff will become a valued member on your team.

Is your company ready to implement electronic publishing services internally?  If so, IMPACT’s Regulatory Operations staff can guide your team through the process of implementing an eCTD program, including software selection, validation, and process development. Please contact us today!