Let's look more closely at these 3 areas and the typical questions that the Regulatory Professional is plagued with.

Compliance

In terms of compliance, the focus is on the registered products and ensuring market penetration of these products. Nothing is more costly - financially and competitively - to a company than missing launch targets or facing a product recall. Questions that need to be answered include:

1. What products (forms, strengths, and presentations) are registered where?
2. Does the product registration application reflect my current manufacturing processes?
3. What changes (change in manufacturing process, new facility, etc) does the company have planned and which registrations are potentially impacted?
4. Do the company's proposed changes make financial sense?
5. What have I committed to do and am I doing it?

Staffing

In terms of staffing, the concerns focus on whether the current team is adequate to meet company goals and whether the staff are knowledgeable about the requirements within the desired market. Questions that need to be answered include:

1. How many FTE's do I need to accomplish my goals?
2. How do I manage the peaks and valleys in workload?
3. Is my staff adequately educated on new requirements imposed by the regulatory authorities in the countries where my products are or will be registered?

Knowledge

It is critical that a company know and understand the requirements for product registrations in the countries in which they want to market their products. It can be an overwhelming task for staff members to keep abreast of the requirements and new initiatives being proposed by regulatory bodies. Questions that need to be answered include:

1. What are the registration requirements for my products in the desired markets?
2. Is the data I plan to generate sufficient for the desired registrations in the desired markets?
3. What new requirements are being proposed and do I need to comply?
4. What new systems and/or processes do I need to plan for to comply with these new requirements?

What Are the Risks of Not being Able to Answer These Questions?

As mentioned, the answer to each one of these questions can impact either the cost of doing business or the revenue generated from the product registrations. Not being able to answer these questions can have dire results. Increased costs and lost revenues can result when a Regulatory Affairs professional cannot answer these and other questions. For example:

1. Fines brought about by audits which uncover manufacturing non-compliance with the currently approved registration documented specifications or processes. These fines can be millions of dollars and quite newsworthy. As a result, these types of problems can also become ammunition for competitors to position themselves as superior thus potentially further impacting revenue.

2. Operational costs that could be lowered by implementing cost-saving modifications to processes are not implemented in a timely fashion due to an inadequate understanding of the impact the change has on the existing registration documentation. For example, when a company cannot determine which version of a document a registration package contains, it will typically spend countless hours searching and verifying which documents were submitted to which authorities and what application need to be updated to reflect a change. A great idea is only that unless it's efficiently and effectively implemented. Manufacturing process improvements can result in 10's or even 100's of thousands of dollars in daily savings once they're implemented. What's frustrating to regulatory professionals can be the daunting and time-consuming process of locating all of the necessary documentation that is impacted by the change, modifying it, possibly getting the change approved by a regulatory authority, and then ensuring that the manufacturing site(s) has read and understood the changes - all the while keeping an audit trail of these activities.

3. Virtually every company has realized that the use of electronic records improves efficiencies. By that same token, these companies also realize that regulations such as 21 CFR Part 11 and Annex 11 impose significant and specific requirements on them for using electronic records strategies. Those who elect to "stick with paper" also elect greater inefficiencies (and internal costs) as well as lost revenue opportunities as paper-based processes and submissions generally take longer to be processed and approved by the regulatory authorities.

4. Hiring of additional staff to meet submission targets and deadlines can be costly. Some companies estimate that preparing a marketing application can require 9 FTE's for 9 months. Regulatory departments at small and mid-size companies rarely have the required staff to manage preparation of an application. Hiring individuals to meet the demands of submission of a marketing application can result in an overstaffed Regulatory department after submission of the application.

Lost revenue on the other hand can be significant when a product launch is delayed, especially when the product has high market demand.

1. Regulatory professionals worry about the content and construction of their submissions and the resultant actions of a Refusal to File (RTF) or a prolonged review process at the regulatory authority(ies) due to questions about the content or a dossier that's difficult for a reviewer to navigate. Adding further complexity are the ever-changing rules and resulting processes brought on by new standards such as the electronic Common Technical Document (eCTD), the Structured Product Labeling (SPL) requirement of the FDA, and the emerging Product Information Management (PIM) initiative in Europe.

2. Initial approval is a momentous event for the company and signifies reaching a key milestone. Keeping that product on the market after initial approval is equally important, too. Marketing authorizations must be maintained and renewed periodically and an oversight in this area can result in a product sitting in the warehouse instead of in the pharmacy while paperwork is hastily sorted out. Many companies lack a centralized database of product renewal dates, an overlooked renewal in just one market can result in the company's lost ability to sell that product in that market until its registration is renewed.

The Key to a Good Night's Rest

Fortunately, Thomson Scientific can help...

The key to worrying less and getting a better night's rest is having the right solutions in place to address these risks and help answer those questions. Thomson Scientific offers a number of solutions to help.

Compliance
Thomson offers Liquent InSight solution suite to the Life Sciences industry. The InSight family of products is designed to ensure and offer regulatory affairs professionals with technology tools they can use in-house to improve their ability to be compliant with the myriad of regulatory requirements. From registration planning to submission planning to eCTD publishing and secure document management, the InSight suite assists these professionals throughout the drug approval and post-marketing workflows in the dozens of markets where their products are sold.

Staffing
Thomson offers business process consulting, medical writing services, clinical data management and submission publishing services for those companies where extra heads and hands are needed. By offering highly skilled regulatory professionals, Thomson's clients can supplement their own teams with world-class expertise.

Knowledge
Through its IDRAC solution, Thomson Scientific offers the world's leading regulatory intelligence database - online and up-to-date with the rules and regulations for drug approval that have been published in over 40 regions around the world. The value-added content that provides further interpretation and explanation of these "rule books", IDRAC helps regulatory professionals to confidently guide their organizations through the maze of drug registration.