Regulatory Strategy, Intelligence, Assessments

Launching a new product or advancement of current products (indications) need to be up to date on timely basis. Also requires accuracy on different stages of development process i.e., from clinical to testing to labeling and to submission formats.

One can search single or multiple country requirements for different business/functional areas including clinical, IRB, market launches, CMC, GMP standards, submission checklists, fees, labeling, import/export, marketing, safety/PV, renewals/variations and life cycle requirements.

Global requirements change regularly. To read or analyze larger documents, translating non-English regulations is a time consuming process. In addition, some countries do not provide detailed regulations and interpreting such short documents need deeper analyzing capacity. Though there is no shortage of updates and documents in various public domains, getting accurate updates faster from authentic sources is the key.

For a detailed alternate search engine, you can rely on our regulatory monitoring process. Once you receive alerts, you can move to next steps like sharing documents internally/externally, collaborating (with our Collaborate/Review functionality) with internal/external stake holders. Further steps are (like document preparation or a project preparation) using workflow and our online commenting functionality. You can also opt for specific preferences i.e., by country and by functional area to get focused alerts.

Regulatory change management is the management of policy, regulatory, and/or procedural changes that apply to your organization. It involves in identifying, interpreting, and applying changes in the regulatory environment to your risk and compliance frameworks, products, and operations. It also requires assessing the impact of changes on products, updating internal processes, and training, and tracking compliance with the updated regulation. Regulatory change management is an ongoing process that can be facilitated by our tools that monitor and document new as well as changed regulations by country and line of business.

Requests and queries to Regulatory teams are increasing daily and most of those teams need a short/quick turn-around pressure on Regulatory function. Regulatory Impact Assessment (RIA) helps to have base decisions on regulatory facts plus evidences. It critically assesses the positive and negative effects of proposed (Guidance) and existing regulations and non-regulatory alternatives.

The purpose of RIA is to ensure that regulations are effective, efficient, and beneficial to the company while minimizing negative impacts. With our assessment module, Regulatory teams can cut down cycle (waiting) time and feel less burdened clearing their “to-do” lists.

RIA typically involves several steps, including:

RIA is a valuable tool for Regulatory teams where it can help them identify the most effective and efficient options while minimizing unintended consequences.