Regulatory Strategy & Submission Support

Streamlining your path to approval – globally.

At IIBAT, we provide expert regulatory strategy, dossier preparation, and compliance consulting to support your submissions for pharmaceuticals, biologics, medical devices, agrochemicals, industrial chemicals, and more. Our team works with you from early development through submission and post-market updates—ensuring your regulatory packages are complete, compliant, and submission-ready.

We align our services with major regulatory frameworks, including FDA, EMA, CDSCO, MHRA, REACH, EPA, WHO, ICH, and ISO standards, helping you navigate complex global requirements with confidence.

📘 Why Regulatory Strategy is Crucial

Even the most scientifically sound product can face delays or rejection if regulatory documentation is incomplete or non-compliant. A solid regulatory strategy:

  • Saves time and reduces the cost of repeat studies

  • Identifies compliance gaps early

  • Aligns data generation with jurisdiction-specific requirements

Ensures your dossier stands up to regulatory review

🧩 Our Regulatory Services

We provide end-to-end guidance on study design, data gap analysis, and dossier preparation across global regulatory frameworks. These services ensure submission success for pharmaceuticals, agrochemicals, devices, and industrial chemicals.

1. Regulatory Strategy & Roadmapping

Objective: Design a development and submission plan tailored to your product, target markets, and timelines.

We provide:

  • Product classification & regulatory pathway identification
  • Market entry planning for FDA, EMA, CDSCO, REACH, EPA, and other regions
  • Risk-benefit and gap analysis
  • Timelines, required data, and study design consultation
  • Advice on accelerated/priority pathways (e.g., fast track, orphan, MRL waivers)

✅ Ideal for startups, innovators, and companies entering new markets

2. Study Design & Protocol Development

Objective: Ensure all studies are scientifically sound, GLP-compliant, and aligned with regulatory expectations.

Support includes:

  • Drafting of GLP & non-GLP protocols (toxicology, pharmacokinetics, efficacy, etc.)
  • Review of existing protocols for compliance and completeness
  • Alignment with ICH M3(R2), OECD, ISO 10993, WHO, EPA, and REACH guidelines
  • Protocols tailored for multisite or integrated study programs

✅ Avoids redundancy, ensures regulatory acceptance of study results

3. Dossier Preparation & Regulatory Submissions

Objective: Compile and submit well-structured, compliant documentation packages for regulatory review.

We support:

  • Pharmaceutical submissions:
    • CTD/eCTD format for IND, NDA, ANDA, BLA, MAA

  • Agrochemical/biocide submissions:
    • REACH registration dossiers (IUCLID)
    • EPA FIFRA submissions

  • Medical device submissions:
    • CE Marking under EU MDR
    • FDA 510(k), PMA
    • Technical files and Summary of Safety and Clinical Performance (SSCP)

  • Biocides and disinfectants:
    • WHO Prequalification dossiers
    • BPR registration (EU)

✅ Assistance with Module 1–5 content, annexes, and regional variations
✅ Submission via secure regulatory portals (e.g., ESG, CESP, REACH-IT)

4. Gap Analysis & Data Remediation

Objective: Identify missing or non-compliant data and propose actionable solutions.

Services include:

  • Review of existing studies and reports
  • Checklist-based evaluations against target authority guidelines
  • Development of data generation plans

  • Bridging studies and scientific justifications
  • Regulatory intelligence updates and harmonisation checks

✅ Saves time and budget by avoiding unnecessary repeat studies
✅ Enhances defensibility of legacy or third-party data

 
5. Compliance Consulting & Regulatory Intelligence

Objective: Keep your processes, studies, and submissions aligned with current global standards.


We provide:

  • Pre-submission meeting preparation (FDA, EMA, CDSCO)
  • Compilation of CMC, non-clinical, and clinical data in regulatory-ready formats
  • Support for GxP compliance across GLP, GMP, and GCP
  • Labelling, claims, and safety data sheet (SDS) reviews
  • Real-time alerts on regulatory changes relevant to your product class

✅ Especially valuable during mergers, acquisitions, audits, or international expansion

Why Choose Us?

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Turnkey support from product ideation to post-market changes

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Integrated with in-house laboratories for faster testing-to-submission cycles

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Proven track record of successful regulatory approvals across sectors