Proactive monitoring of regulation changes to assess the impact to your product portfolio

Heightened competition and globalisation requires life sciences companies to extend their global footprint. But with new markets come new regulatory challenges, and the more complex the portfolio, the greater the hurdles that must be overcome. Added to this is the fact that regulatory departments must also stay up-to-date with product lifecycle management and regulatory changes.

Navigating the global regulatory landscape

Celegence helps you navigate increasingly complex and stringent global regulatory requirements while improving and standardising processes across functions and geographies.
Our global regulatory experts offer insights on regulatory strategy and we draw on a local regulatory network to support geo-specific requirements. This global network enables us to deliver up-to-date, robust global regulatory intelligence services to enhance product development and registration strategies.

Robust database support

To support global intelligence reporting, Celegence is also developing an international database solution. The objective is to help the life sciences industry monitor global requirements, share information and manage regulatory strategy for a complex product portfolio.

Regulatory Affairs teams will be able to collect, store and share regulatory information based on previous submissions, experience and regulatory monitoring. These valuable insights will assist with future submissions.

Celegence can help your business with the following dedicated global regulatory intelligence services:

  • Intelligence on regulatory requirements – including submissions for clinical trials, marketing authorisations, post-marketing maintenance and understanding global and regional regulatory requirements
  • Impact analysis reports – helps organisations understand how changing regulations impact the product portfolio
  • Reports on current trends – including regulatory operations, interpretation of regulatory information to improve processes and KPIs
  • Regulatory submission strategy — based on internal data and current/future regulations specific to product types, therapeutic areas and geographical regions
  • Global and local regulatory submission consulting – assists companies with defining and monitoring the regulatory submission plan
  • Storage of ‘soft’ intelligence – we provide a centralised repository for internal and external regulatory intelligence documents

 

Learn more about our niche service offerings:

MEDICAL WRITING

Medical writing – delivering specialty knowledge

MEDICAL DEVICES

Medical devices – addressing a changing regulatory environment

REGULATORY LABELING

Regulatory labelling – supporting clients from creation to maintenance

PUBLISHING AND ECTD SERVICES

Publishing and eCTD services – tackling global submission challenges

REGULATORY OPERATIONS MANAGEMENT

Managed regulatory operations related to publishing, submission and regulatory information management for reduced total cost of ownership

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