PA has a proven approach to managing regulatory information that ensures pragmatic analysis of key requirements (such as business process, functional, technical, training, QA, security and audit,requirements) which leads to an outcome that is more likely to be right first time
Our capability is gained from: working across pharmaceutical and healthcare sectors and experience of clinical, development, regulatory, manufacturing and commercial processes and systems; successful cross-functional requirements analysis, design and deployment of integrated electronic submissions support systems; providing compliant system solutions (including compliance with 21CFR Part 11); and large scale systems deployment and integration in corporate settings.
PA delivers in three key areas of regulation management:
- devising strategies that offer the greatest benefit
- supporting electronic submissions
- providing compliant system solutions.
Devising strategies that offer the greatest benefit
The pharmaceutical industry has recognised the benefits of a strategic approach to managing regulatory information. The goal is information integration throughout R&D, eliminating most internal paper flows. While this offers a whole stream of electronic submissions at less overall cost, it cannot deliver them until it has been used for a number of years to capture information in electronic formats at the point of creation. For those who have not yet successfully introduced across-the-board electronic integration for regulatory information, the eventual benefits can be:
- three to six months' saving in the time from freeze of last study data to putting together the first dossier, thanks to removing the mountain of copying and collation
- a saving of man-years in the review time when preparing the submission, because study data is immediately available to the internal reviewer to support rapid analysis and decision making
- easily reformatted core information to support synchronised filings in other markets
- use of these validated electronic submission systems as an organised knowledge base to facilitate development of follow-on compounds.
These benefits can be achieved only by a strategy which agrees worldwide standards, formats and templates, provides them to clinical data management and document creation groups, and captures and validates electronic versions of all regulatory records as the studies are completed and written up.
Supporting electronic submissions
We have a proven track record working in the pharmaceutical industry, across R&D to support electronic submissions. Key areas of our capability include:
- pharmaceutical R&D process improvement and organisational change
- improvement of compilation and tracking processes for paper and electronic regulatory submissions
- implementation of document management systems
- strategies for information management and audits of records management, through to the full implementation of document management systems.
We have delivered important benefits for clients including greater efficiency and productivity through improved document management supporting electronic submissions.
Providing compliant system solutions
Our life sciences experts have hands-on experience of cGMP, GLP and GCP, and understand the underlying compliance requirements during implementation of new processes, systems and product development. We have provided our many clients with an independent audit of facilities and systems focused on their particular cGMP concerns, including:
- cGMP audits on active pharmaceutical ingredient and finished product manufacturers against FDA and EMEA cGMP requirements
- structured reviews of the processes and IT systems used to assure cGMP compliance
- implementation of improvement programmes.
PA understands the Regulated GMP environment under which pharmaceutical manufacturing systems operate, and has a proven approach to addressing implementation compliance with ERES regulations (eg 21 CFR Part 11). Pharmaceutical industry computer systems and electronic data have become an integral part of the drug development and manufacturing process. Data generated must comply with FDA regulations, and the regulations are subject to measures that ensure the integrity of computer system operations and data storage.
Further information
For further information please e-mail: healthcare@paconsulting.com
