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 regulatory project, as it directly impacts feasibility, timelines, and costs, ultimately reducing the times until the launching to market and ensuring compliance of the normative in each country where you intend to register the product.

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 so your product meets all necessary regulatory requirements of each country selected for the registration. 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. In additional, it ensures a trouble-free marketing life cycle.

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, helping you comply 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, submission and assessment success from competent authorities.
• Dossier Preparation and Submission: we manage the preparation of dossiers in eCTD format, guaranteeing 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), making sure that all documentation is in the appropriate format 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 in buying and selling licenses and dossiers, offering smooth intermediation between the parties to ensure that our client’s objectives are met.

  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 verify that patient information leaflets are clear and comprehensible for the patients, meeting regulatory standards.
  • MAH Services: we assist in the preparation of all necessary documentation for registering your medicine as a Marketing Authorization Holder (MAH). This includes support for preparing Quality documentation and Pharmacovigilance services, 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 making sure your your products meet all regulatory requirements, paving the way for a successful and timely market launch. Let us assist you in streamlining your regulatory processes, reducing time to market, and achieving compliance for your pharmaceutical products.