Regulatory compliance and quality management

To safeguard patients and ensure product reliability, pharmaceutical, biotechnology and healthcare companies have to stay compliant with complex regulatory requirements. From preclinical and clinical development to regulatory operations and market authorization, we provide compliance and quality services across the life cycle of your health care product.

Comprehensive, flexible, skilled support

USPs

  • Our expertise covers the domains of documentation and submission management, registration management and end-to-end labeling management throughout the product life cycle to accelerate and maintain market authorization.
  • We work alongside your team to provide business-specific consultancy on regulatory information management, submission, e-TMF and quality-related process areas.

Service overview

  • Our team develops regulatory scenarios to align decision-making with your company’s strategy.
  • We translate your regulatory strategy into realistic deliverables.
  • We support the integration of acquired companies into your quality and regulatory processes and systems, and help you establish regulatory intelligence to meet local requirements and timelines.
  • We assist you in implementing efficient regulatory operations by supporting the creation of a data-driven regulatory organization.
  • We identify compliance risks and develop risk mitigation strategies.
  • We provide operational support and process improvement from trigger and labeling updates to implementation in packaging components. In addition, we can support you in handling special events such as Brexit.
  • We help establish data integration across the product lifecycle between different stakeholders to assure oversight over your complete product portfolio.
  • We provide content management consultancy for regulatory and quality-driven processes.
  • We offer the IT skillsets you need to support the implementation of e-TMF, regulatory information management (RIM), submission documents, quality documents and quality management systems (QMS).
  • By organizing cross-functional regulatory deliverable review workshops, we help you accelerate market authorization.

Our Experts

You can count on professional support from regulatory affairs and quality experts that share our values of trust, close cooperation and excellence.

  • Business consultants
  • Project managers
  • Business and IT analysts
  • Regulatory project managers
  • Pharmacists
  • Writers specialized in regulatory affairs and quality

Target markets

From biotech to diagnostics, Modis offers you the specialisms that your business case requires.

  • Biotechnology
  • Pharma
  • Medical devices
  • Diagnostics

Supporting IT Tools

Every project requires different types of collaboration, content management and knowledge-sharing activities. We’re familiar with all industry-leading tools.

Veeva Vault is a cloud-based content management platform developed for life sciences enterprises. It allows your business to manage content and data to eliminate siloes and streamline your clinical processes.

Modis is a certified Veeva Technology Partner. As one of the first partners in Europe, our experts have in-depth knowledge of Veeva Vault applications in the domains of submissions, clinical trials and quality. Our expertise in mapping and translating business processes, content migration, security, validation support, rollout, governance and operational support means that we can help you get the most from Veeva Vault.

Back

Modis helps pharma leader with a retrospective labeling compliance program

Client core business

The customer is a Belgium-based pharmaceutical company developing treatments for serious disorders, such as cancer, hepatitis, HIV/AIDS, diabetes, arthritis, dementia and mental disorders.

How Modis added value

Our team helped the company implement a retrospective labeling compliance program that reviews the labeling of its products worldwide. We helped by:

  • designing relevant business processes;
  • translating business needs into functional and technical specifications;
  • implementing SharePoint for a structured work environment and continuous monitoring capabilities;
  • providing support throughout the project lifecycle;
  • managing the project at all levels.

By automating labeling compliance, the company now has more resources to dedicate to its core business of drug development.

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