Global Stability Study Protocol & Report Services

StabilityPro - Global Stability Study Protocol & Report Services

Regulatory-Compliant | Authority-Ready | Globally Trusted

StabilityPro, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Stability Study Services, including preparation and review of Stability Protocols and Stability Reports with graphical data, aligned with global regulatory expectations.

Since 2008, we have successfully supported 510+ products with stability documentation and regulatory query handling for clients across Asia, Middle East, Africa, Europe, and LATAM markets.

Who We Are

StabilityPro is a specialized scientific and regulatory service provider focused exclusively on stability study documentation, data interpretation, and authority response support.

We work as an extension of your QA, QC, and Regulatory Affairs teams, ensuring that stability data is:

• Scientifically sound

• Statistically meaningful

• Regulatory-acceptable

• Inspection-ready

All activities are executed by experienced formulation scientists, stability experts, QA professionals, and regulatory specialists.

Our Stability Study Services

🧪 Stability Protocol Preparation

• Long-term, accelerated & intermediate study protocols

• Zone-specific protocols (ICH, ASEAN, GCC, LATAM, ROW)

• Product-specific protocols (FDP, API, cosmetics, food, etc.)

• Container-closure system-based protocol design

• Bracketing & matrixing strategy support

• Photostability & in-use stability protocols (where applicable)

📊 Stability Report Preparation

• Interim, annual & final stability reports

• Trend analysis & data interpretation

• Shelf-life justification & retest period justification

• OOS / OOT evaluation and scientific rationale

• Conclusion aligned with regulatory filing strategy

📈 Graphical Data & Trend Analysis

• Stability graphs (assay, impurities, dissolution, physical parameters)

• Batch-wise and parameter-wise trending

• Visual representation acceptable to MOH / FDA reviewers

• Clear interpretation for regulatory submissions

📝 Stability Document Review Services

• Independent technical & regulatory review of:

  • Stability protocols

  • Stability reports

  • Graphs & trend summaries

• Gap assessment against current regulatory guidelines

• Correction of deficiencies flagged by authorities

🧾 Regulatory Query Handling – Post Operations

• MOH / FDA stability-related deficiency responses

• Scientific justifications & rebuttals

• Data re-presentation & revised graphs

• Lifecycle stability commitments & variation support

Industries We Serve

We provide stability study documentation services across a wide range of regulated and semi-regulated industries:

• Finished Dosage Products (FDP) – Pharmaceuticals

• APIs / Bulk Drugs

• Cosmetics & Personal Care Products

• Herbal, Ayurveda & Natural Extracts

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

Why Choose StabilityPro

✔ 510+ products supported globally
✔ Experience across regulated & ROW markets
✔ Authority-acceptable documentation style
✔ Strong scientific justification approach
✔ End-to-end support from protocol to approval
✔ Fast turnaround with compliance focus
✔ Confidential, client-centric execution

Global Regulatory Alignment

Our stability services are aligned with:

• ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E

• WHO Stability Guidelines

• FDA, EMA, MHRA expectations

• ASEAN, GCC & LATAM requirements

• Country-specific MOH expectations

Who We Support

• Pharmaceutical manufacturers

• API manufacturers

• Contract manufacturers (CMOs / CDMOs)

• Exporters & traders

• Regulatory consultants

• Brand owners & marketing authorization holders

Let’s Talk Stability

Whether you need new stability documentation, review of existing data, or regulatory query support, StabilityPro ensures your stability package is scientifically robust and authority-ready.

📩 Contact us today to discuss your stability study requirements.

“Stability Protocols & Reports. Authority-Ready. Globally Trusted.”

Excellence in Stability Research & Compliance.

📌 Frequently Asked Questions (FAQ) – Global Stability Study Protocol & Report Services

Frequently Asked Questions (FAQs)

1. What stability study services does StabilityPro provide?

StabilityPro provides end-to-end stability study services including preparation and review of Stability Protocols, Stability Reports with graphical trend analysis, and regulatory query handling. We support the complete lifecycle of stability documentation—from study design to authority response.

2. Do you conduct laboratory stability testing?

No. StabilityPro is a scientific documentation and regulatory support service provider. We do not perform physical testing, but we prepare, review, interpret, and present stability data generated by GMP/NABL/ISO-accredited laboratories or manufacturing sites.

3. Which guidelines are followed for stability documentation?

Our stability protocols and reports are prepared in accordance with:

• ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E

• WHO Stability Guidelines

• FDA, EMA, MHRA expectations

• ASEAN, GCC, LATAM & ROW country-specific MOH requirements

4. What types of stability studies do you support?

We support:

• Long-term stability studies

• Accelerated stability studies

• Intermediate stability studies

• Photostability studies

• In-use stability studies

• Ongoing / annual stability studies

• Bracketing & matrixing studies

5. Which products are covered under your stability services?

We provide stability documentation services for:

• Finished Dosage Products (FDPs)

• APIs / Bulk Drugs

• Cosmetics & Personal Care Products

• Herbal & Ayurvedic Products

• Essential Oils & Fragrances

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

6. Do you prepare stability graphs and trend analysis?

Yes. StabilityPro prepares clear, regulator-friendly stability graphs, including:

• Assay trending

• Impurity/degradation product trends

• Dissolution trends

• Physical parameter trends
  Graphs are prepared in formats commonly accepted by global regulatory authorities.

7. Can you review and correct existing stability protocols or reports?

Yes. We offer independent technical and regulatory review of existing stability protocols, reports, and graphs. We identify gaps, correct deficiencies, and align documents with current regulatory expectations.

8. Do you handle MOH / FDA queries related to stability studies?

Yes. We provide post-submission stability query handling, including:

• Scientific justifications

• Revised stability reports or graphs

• Shelf-life or retest period justification

• Commitments and follow-up responses to authorities

9. For which countries do you provide stability documentation support?

We support clients and regulatory submissions in Asia, Middle East, Africa, Europe, and LATAM regions, including both regulated and ROW markets.

10. How many products has StabilityPro supported so far?

StabilityPro has successfully supported 510+ products with stability protocol preparation, report writing, review, and regulatory query handling.

11. Can you prepare stability documents for new product registrations?

Yes. We prepare submission-ready stability protocols and reports for:

• New product registrations

• Line extensions

• Variations & renewals

• Technology transfer projects

12. Do you provide confidentiality for client data?

Absolutely. All client data, stability results, and regulatory documents are handled under strict confidentiality and, if required, Non-Disclosure Agreements (NDAs).

13. Who typically uses StabilityPro services?

Our services are used by:

• Pharmaceutical & API manufacturers

• CMOs / CDMOs

• Exporters & traders

• Brand owners

• Regulatory consultants

• QA & RA departments

14. Can StabilityPro support multiple batches and multiple strengths?

Yes. We routinely handle multi-batch, multi-strength, and multi-pack stability data, including bracketing and matrixing approaches where justified.

15. How do we start working with StabilityPro?

You can start by contacting us with:

• Product details

• Dosage form / category

• Stability data availability

• Target market(s)
  Our team will review your requirement and propose a customized stability documentation plan