Regulatory Compliance and Gap Analysis

Regulatory Compliance and Gap Analysis

I. Importance of Regulatory Assessment and Gap Analysis for Medicinal Products The registration of medicinal products requires thorough documentation and data analysis to ensure compliance with regulatory requirements. While most Health Authorities accept CTD format submissions, the content required in each section can differ. Conducting a regulatory assessment and gap analysis enables manufacturers to identify and address any gaps in their documents and data before submitting to regulatory authorities. This process helps prevent regulatory rejections and minimize major or critical queries, ultimately expediting the approval process.

II. Mitigating Compliance Gaps with Legacy Dossiers Performing a gap analysis of legacy dossiers against current manufacturing practices can help manufacturers ensure their products are compliant with regulations. The analysis identifies gaps that need mitigation by submitting supplements or variations. Mitigating non-compliant regulatory practices can ensure successful product registration and market launch.

III. Templarpharma’s Regulatory Support for Gap Analysis Templarpharma is a trusted regulatory service provider with experienced regulatory affairs CMC resources. The company offers gap analysis support to assist manufacturers in meeting regulatory compliance requirements. Templarpharma’s regulatory experts conduct a thorough analysis of documents and data to identify any gaps, providing actionable recommendations for mitigating compliance risks. Templarpharma’s services expedite the regulatory approval process, ensuring a timely product launch.

Templarpharma Expertise in Regulatory Compliance and Gap Analysis

  • Conduct a thorough assessment of the regulatory submission strategy.
  • Perform a regulatory compliance and gap analysis of the supporting documents and data generated during the product development stage.
  • Review the qualitative and quantitative composition of the medicinal product to ensure its acceptability.
  • Establish impurity limits in accordance with ICH requirements based on MDD.
  • Conduct a gap analysis of the protocols and reports for product development, process validation, stability program, exhibit batches, batch size for registration, and hold time study.
  • Select the appropriate dissolution method and parameters.
  • Determine the biowaiver criteria for the product.
  • Assess the existing dossier for market expansion and identify any gaps.
  • Determine the region-specific stability study requirements.
  • Conduct a gap analysis of the draft CTD package to ensure its adequacy for submissions such as INDs, IMPDs, CTAs, NDAs, MAAs, DMFs, and dossiers.
  • Conduct a technical review of change controls to ensure compliance with regulatory requirements.
  • Develop a variation/supplement submission strategy and provide suggestions for addressing any identified gaps.