At Premier Research, we bring decades of specialized expertise in preparing regulatory submissions, with a focus on electronic Common Technical Documents (eCTDs) for small to midsize pharmaceutical, biopharmaceutical, and medical device companies. Our team of trusted professionals goes beyond document compilation—we expertly craft electronic dossiers that align with the evolving standards of global regulatory agencies, helping to accelerate and streamline the review and approval process.

A combination of deep expertise and client-first service allows us to meet and exceed regulatory requirements, guaranteeing a seamless submission experience.

• Deep Experience: Our team brings decades of deep, specialized experience—ranging from paper submissions to the latest eCTD formats. Health authorities supported include FDA, EMA, MHRA, HC, UK, Swissmedic, MedSafe. Submission types supported include but are not limited to NDA, NDS, ANDA, BLA, IND, IDE, CTA, MAA, 510K, PMA, ODD, Master Files, RMAT, INTERACT, RDPP, QIPD. 
• Tailored Solutions: We focus on the nuances and context of each project, offering personalized service tailored to specific needs, putting our customers first.
• Global Collaboration: Collaboration is at the heart of our approach. With teams strategically located in the US and India, we provide round-the-clock support, ensuring flexibility and responsiveness across multiple time zones.
• Regulatory Expertise: Our regulatory professionals are fully equipped to navigate the evolving complexities of global submission requirements with confidence.
• Technology Enabled: Our publishing and validation software run the latest releases to ensure compliance with current regulatory policies. These systems are fully validated and regularly backed up to maintain optimal performance, data integrity, and security.

Comprehensive Submission and Publishing Services

We offer both document-level preparation and submission publishing for a broad spectrum of applications, with a strong focus on eCTD.

Document Preparation

Our specialists do more than just format, we ensure every document is consistent, accurate, and fully compliant with the specific requirements of regulatory agencies. We manage critical submission materials across all modules, with expertise in preparing and supporting:

• Study Protocols
• Investigator Brochures (IBs)
• Clinical Study Reports (CSRs)
• Nonclinical Study Reports
• Chemistry, Manufacturing, and Controls (CMC) Documentation
• Investigational Medicinal Product Dossiers (IMPDs)
• Labeling Content
• Summaries
• Integrated Summaries of Safety and Efficacy (ISS/ISE)
• Development Safety Update Reports (DSURs) / Annual Reports
• Regional-Specific Documents

Submission Publishing

We support regulatory submissions from early development through post-approval, delivering structured, compliant eCTD dossiers tailored to client’s needs. Whether it’s a single amendment or a full marketing application, our team ensures seamless progress at every stage of the regulatory lifecycle.

Services include:

• Pre-IND, INTERACT, and Q-submission support
• Amendments, supplements, and lifecycle management
• Marketing Applications
• Post-approval regulatory commitments
• Promotional Material submissions
• Clean, compliant dossier preparation and publishing

Partner With Premier Research for Success

When you partner with us, you gain a strategic advantage in navigating the complexities of regulatory submissions by minimizing delays, reducing risk, and accelerating the path to approval with greater confidence. Contact Premier today to discuss your submissions and publishing needs.