Case Study: Regulatory and Market Intelligence Support for a Top-Tier Biotechnology Firm

Background – Client Needs:

A top-tier biotechnology firm based in the United States approached Celegence for Regulatory intelligence support, which necessitated gathering, analysing, and interpreting data from multiple sources to gain insight into the latest regulatory environment and how it impacts the life science industry. The scope included gathering market intelligence also where required.

The Client Faced the Following Challenges:

The life science industry has been dealing with increasingly stringent regulatory requirements over the past few years. These regulations have created a range of challenges for life-science companies, such as:

  • the need to comply with ever-changing laws, standards and regulations;

  • the need to meet stringent quality and safety standards;

  • the need to keep up with the latest technology;

  • the need to comply with the tight timelines

  • and the need to keep up with the competition

Project Initiation & Key Objectives:

The client chose Celegence’s team of domain experts for providing strategic guidance on regulatory challenges, assessing impacts, and providing intelligence reports, as the team is well‑versed with the current regulatory environment.

Celegence Solution & Approach:

Celegence was awarded a contract to provide Regulatory intelligence services detailing requirements for:

  • The initial pilot was on collecting regulatory intelligence on Patient Safety (Pharmacovigilance) requirements of the specific drug products across about 30 countries. The countries spread across the globe are the USA, Latin America, Europe, Africa, Asia-Pacific, the UK, etc.

  • The market and retail information of various pharmaceutical products across different countries. It includes an overview of the current marketing approval status and marketing approval holder (MAH) details. The analysis looks at key factors such as product launch details, an in-depth analysis of product availability, wholesaler and distributor details from which the product can be procured, contact details, retail price, etc.

  • Comparability protocols (CP) guideline, recently published by The Food and Drug Administration (FDA) to assess the impact of post-approval changes to the Chemistry, Manufacturing, and Controls Information (CMC) of a drug product. An assessment of the impact of post-approval changes on the product quality and other considerations, such as evaluating the nature and extent of the change, the analytical methods and the control strategy, and the potential effect of the proposed change on the product’s identity, strength, quality, purity, and potency (in align with ICHQ12) was performed with the major regulation that is implemented across various developed/ developing countries/regions highlighting the similarities and differences.

  • New clinical evaluation guideline for medical devices, GN-20 – Guidance on Clinical Evaluation (Rev. 2, Nov-2022), recently published by The Health Sciences Authority (HSA) in Singapore, outlines the clinical evaluation requirements for medical device manufacturers and other stakeholders to update the data types, information that should be included in a clinical evaluation report, and the requirements for monitoring and reporting adverse events to ensure the safety and effectiveness of the medical devices in question. An assessment of the impact of the new guidelines on the requirements for clinical data, risk analysis and management, and post-market clinical follow-up was performed with the major regulations from around the world, highlighting the similarities and differences.

  • Another area of focus was on the Pharmacovigilance inspection program guidance published by the Australian regulatory authority TGA, the Guidance for medicines sponsors. Celegence had to review the guidance in detail and provide an extensive report on its impact on the industry, its comparable guidances in other health authorities such as EMA, USA, Canada, etc.

Approach:

Creating a comprehensive approach for meeting the ever-changing laws, standards, and regulations was essential, and to achieve it efficiently, the Celegence team first tried to understand the regulations across the regions by gathering the information from Regulatory agencies’ websites, Regulatory platforms, concepts or published papers, and Guidance documents, and how they interact with one another.

Once the corresponding guidance(s) across the countries were identified, the Celegence team began an in-depth analysis of the impact on the industry and prepared a comprehensive Regulatory intelligence report that includes Regulatory updates, current trends, data analysis, implications on industries, potential pitfalls, impact on the timelines, etc.

Solution:

  • Stay Up to Date with Regulatory Changes: Celegence’s Regulatory intelligence services help life-science companies stay up to date with changing regulations, allowing them to adjust quickly and effectively.

  • Being Prudent: Regulatory intelligence can aid companies in recognizing current movements in the industries, like when specific regulations are becoming more or less desirable.

  • Make Informed Decisions: Celegence’s Regulatory intelligence allows companies to make informed decisions that are in compliance with global/local regulations. This helps them avoid costly fines and other penalties.

  • Improve Compliance: By staying up to date with the latest regulations, companies can improve their compliance and reduce the risk of non-compliance.

  • Enhance Reputation: Following regulations help companies build a good reputation, while not complying can damage a company’s reputation.

  • Gain a Competitive Edge: By having an understanding of the regulatory environment, companies can gain a competitive edge over their competitors.

  • Protect Intellectual Property: Regulatory intelligence can help companies protect their intellectual property from competitors who may try to imitate their products or services.

  • In-house Expertise: Celegence’s global experts and capabilities facilitate the expansion of Life-sciences companies into new markets in an expedited manner. Regional Regulatory experts, who possess a thorough understanding of local Regulatory requirements, are invaluable resources that also caters to various regional services in the field of Regulatory Affairs, Regulatory Information Management System, End-to-end submission & publishing, Regulatory/Medical Writing (Pharma and Medical Devices), Labelling management, product life cycle management, CMC, and Medical Devices Registration.

Project Achievements

Celegence delivered the following value and business impact to the client:

  • 1

    Comprehensive and accurate registration requirements, including steps, fees, and average timeline, in order to inform regulatory strategy and minimize potential delays.

  • 2

    Ability to recognize relevant information and provide only useful or necessary data avoiding ‘data dump’.

  • 3

    Analysing the regulatory information along with the risk mapping and having an accurate impact analysis performed based on the customer’s product portfolio.

  • 4

    Preparing a succinct, comprehensive, simple, and accurate Regulatory intelligence report that compares the overall market trends and analyses the implications for the future.

  • 5

    Ongoing compliance improvement with access to Celegence’s regulatory expert network.

Project Success

The keys to the project’s success were proactive and strategic planning, delegation of duties to the skilled and informed team, effective communication and collaboration between Celegence and the customers, and a unified effort throughout the duration of the project.

In order to ensure the success of the project, all the components had to be properly aligned and working together. The team created a plan tailored to the project’s requirements and allowed for efficient communication between all the stakeholders.

Followed a well-defined project management approach with optimum use of project resources, high quality and timely delivery of the outcome. By delegating duties to the most knowledgeable members and ensuring that all team members were on the same page, the project was able to progress smoothly and come to an effective conclusion.

Get in touch today to discuss your regulatory needs by reaching out to info@celegence.com or contact us online.