Regulatory Strategy, Intelligence, Assessments -

Regulations are in constant flux. Companies product and country strategies keep changing. Product lifecycle changes bring opportunities and risks

New Product Launches

Launching products or variants of current products (indications) need to ensure UpToDate and accurate requirements ranging from clinical to testing to labeling and submission formats.

You can search single or multi 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.

Regulatory Monitoring

Global requirements change often. To read or analyze long/large documents, translate non-english regulations is time consuming. In addition, some countries do not provide detailed regulations and interpreting their short documents need deeper experience. Though there’s no shortage of updates and documents in public domain, challenge is getting accurate updates faster from authentic sources is the key.

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

Regulatory Change Management

Regulatory change management is the management of policy, regulatory, and/or procedural changes that apply to your organization1. It involves 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 and changed regulations by country and line of business

Impact Assessment

Requests and queries to Regulatory teams are increasing daily and most of those teams need a short/quick turn-around putting pressure on Regulatory function. Regulatory impact assessment (RIA) helps to base decisions on regulations on facts and evidence. 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:

1. Problem identification: Identifying the issue or problem that the regulation is intended to address.

2. Strategy development: Developing a range of policy options to address the problem.

3. Impact analysis: Assessing the potential impacts of each option, including the economic and patient safety impacts.

4. Consultation: Consulting with stakeholders and affected parties to gather feedback on the proposed options.

5. Decision-making: Selecting the preferred option based on the analysis and consultation.

6. Monitoring (Project Monitoring) and review: Monitoring the implementation of the regulation and reviewing its impact over time.

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