At Pharmaceutical Innovation Services S.L., we specialize in Regulatory Affairs, offering unparalleled expertise in crafting the optimal regulatory strategy to meet your needs in diverse markets. Establishing a robust regulatory strategy is a critical component of any pharmaceutical project, as it directly impacts the feasibility, timelines, and costs, ultimately reducing the time to market and ensuring compliance with global standards.

Regulatory Strategy 

Our approach begins with a thorough understanding of your product and the markets you aim to enter. We provide tailored advice on the regulatory strategy that aligns with your objectives, ensuring that your product meets all necessary regulatory requirements from the very beginning. This proactive approach not only facilitates a smoother path to market but also helps in identifying potential hurdles early on, allowing for strategic adjustments that save both time and resources.

Regulatory Services Tailored to Your Needs

At Pharmaceutical Innovation Services S.L., we offer a comprehensive range of services in Pharmaceutical Regulatory Affairs designed to support every stage of your product’s lifecycle. Our team of experts is equipped to handle the following regulatory services:

• Regulatory Strategy Advice: We provide expert guidance on the optimal regulatory strategy for your product, ensuring compliance with the specific requirements of each target market.
• Scientific Advice Requests: We assist in preparing and submitting requests for Scientific Advice from all relevant Health Authorities, a crucial step in ensuring that your development plans align with regulatory expectations.
• Dossier Audits and GAP Analysis: We conduct thorough audits of regulatory dossiers, identifying gaps and providing actionable recommendations to enhance compliance and submission success.
• Dossier Preparation and Submission: We manage the preparation of dossiers in eCTD format, ensuring that all regulatory documents are accurately compiled and ready for submission at a global level. This includes Pre-clinical and Clinical sections, Investigational Medicinal Product Dossiers (IMPDs), and responses to regulatory inquiries.
• Regulatory Dossier Management: Our team handles the complete management and uploading of dossiers in eCTD Software (Latok), ensuring that all documentation is correctly formatted and submitted according to regulatory standards.
  

  Lifecycle Management and Licensing Support

  Managing the lifecycle of a medicinal product requires ongoing attention to detail and compliance with evolving regulatory requirements. Our services include:

  • Lifecycle Management: We provide comprehensive management of a medicinal product’s lifecycle, including handling variations, renewals, and notifications. This ensures that your product remains compliant throughout its market life.
  • Licensing Collaboration: We offer support for licensing activities, both in and out, facilitating smooth transitions and partnerships that align with your strategic goals.

  Additional Regulatory Support Services

  In addition to the core regulatory services, Pharmaceutical Innovation Services S.L. offers:

  • Readability Test Preparation: We prepare and conduct readability tests to ensure that patient information leaflets are clear and comprehensible, meeting regulatory standards.
  • MAH Services: We assist in the preparation of all necessary documentation for registering your Company as a Marketing Authorization Holder (MAH). This includes support for Quality and Pharmacovigilance documentation, as well as assistance with implementing Good Distribution Practice (GDP) certification.

  Why should you trust Pharmaceutical Innovation Services S.L. for your Regulatory Affairs needs?

  With our extensive expertise in Pharmaceutical Regulatory Affairs, Pharmaceutical Innovation Services S.L. is your trusted partner in navigating the complex regulatory landscape. We are committed to ensuring that your products meet all regulatory requirements, enabling a successful and timely market launch. Let us help you streamline your regulatory processes, reduce time to market, and ensure global compliance for your pharmaceutical products.