Making clinical research crystal clear

Regulatory Services

At Krystelis, we understand that navigating the complex and ever-evolving landscape of pharmaceutical regulations is critical for the successful development, approval, and commercialisation of medical products. Our comprehensive regulatory services are designed to support pharmaceutical companies at every stage of the product lifecycle, from early development through post-market compliance. By leveraging our deep industry expertise and advanced technological solutions, we ensure that our clients can achieve timely market access, maintain regulatory compliance, and ultimately bring safe and effective products to patients around the world.

Regulatory Services

Regulatory Strategy and Consulting

  • Regulatory Expertise: Monitoring regulatory trends and providing expert guidance on opportunities and challenges that pharmaceutical companies encounter while navigating the evolving regulatory landscape. Our teams support clients by conducting thorough assessments of their regulatory strategies and addressing any challenges.
  • Regulatory Risk Assessment: Identification and mitigation of potential regulatory risks throughout the product lifecycle.
  • Global Regulatory Strategy: Development of tailored regulatory strategies for global markets, including the US, EU, and emerging markets.
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Regulatory Submissions and Documentation

  • Preparation of Regulatory Submissions: Authoring, compiling, and submitting high-quality regulatory submissions such as Investigational New Drug (IND) Applications, Investigational Medicinal Product Dossiers (IMPD), Clinical Trial Applications (CTAs), Briefing Packages, New Drug Applications (NDAs), Biological Licence Applications (BLAs), Marketing Authorisation Applications (MAA), and more.
  • eCTD Publishing and Submission: Electronic submission of regulatory documents in eCTD format, ensuring compliance with regulatory agency requirements.
  • Lifecycle Management: Ongoing support for regulatory submissions, including post-approval changes, annual reports, and renewals.
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Regulatory Due Diligence

  • Due Diligence: Comprehensive regulatory due diligence assessments for mergers, acquisitions, and portfolio expansion.
  • Regulatory Audits: Conducting internal and external audits to assess compliance with regulatory standards and guidelines

Labeling and Promotional Review

  • Labeling Development and Review: Creation and review of product labels, ensuring compliance with regulatory requirements and accurate representation of product information.
  • Promotional Materials Review: Evaluation of promotional materials for compliance with regulatory standards and guidelines, including advertising and marketing claims.
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Regulatory Intelligence and Training

  • Regulatory Intelligence: Monitoring and analysing regulatory developments, providing insights and updates on changes in regulatory requirements and guidelines.
  • Regulatory Training: Conducting training programs and workshops to educate clients on regulatory requirements, submission processes, and compliance best practices.

Advantages of Using Krystelis Regulatory Services

Expertise

Our team of seasoned regulatory experts brings extensive experience and in-depth knowledge of global regulatory requirements.

Efficiency

We streamline the regulatory process, reducing time to market and ensuring timely approvals.

Customisation

Tailored regulatory strategies and solutions to meet the specific needs of each client and product.

Compliance

Rigorous adherence to regulatory standards and guidelines, ensuring compliance and minimising risks.

Support

Ongoing regulatory support throughout the product lifecycle, from development to post-market activities.

Global Reach

Expertise in navigating regulatory requirements in multiple regions, facilitating global market entry and expansion.

Partnering with Krystelis for regulatory services ensures that your pharmaceutical products meet all necessary regulatory requirements, enabling a smoother path to market and sustained compliance.
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