Stability Study Services – Morocco

Stability Protocol Preparation (Morocco DMP Aligned)

• Long-term, accelerated & intermediate stability study design

• ICH climatic zone–appropriate storage conditions
  (Zone II / IVa as applicable based on product & distribution conditions)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1A–Q1F, WHO TRS & Morocco DMP guidance

Stability Report Preparation

• DMP-ready stability study reports

• Scientific evaluation and interpretation of stability data

• Shelf-life / expiry dating & retest period justification

• OOS / OOT assessment and conclusions

• Suitable for new registrations, renewals & post-approval variations

Graphical Trend Analysis

• Assay, impurities, dissolution & critical quality attribute trending

• Statistical analysis with early OOT detection

• Batch-to-batch & strength-wise comparison

• Authority-friendly graphical presentations

DMP Regulatory Query Handling

• Response to Morocco DMP stability-related queries and deficiencies

• Shelf-life extension & scientific justification support

• Assistance during regulatory review cycles and GMP inspections