CMC documentation management to Services in regulatory affairs

Your CMC documentation:

  • is vital from early drug development through regulatory submission and to the late post-approval stage;
  • must fulfil global regulatory as well as local requirements;
  • covers a wide range of activities and describes drug production, testing and control;
  • tends to get more complicated and extensive when a drug moves from concept in early R&D to a final product in commercial phase.

Why use our support with CMC documentation?

Arex Advisor’s CMC specialists have the experience to guide you throughout the CMC life cycle as well as provide operational support with drafting or reviewing CMC documentation.

We help you with:

  • preparing the IND / IMPD
  • your MAA / ANDA/ NDA / BLA, where we can author or review the quality overall summary or any module 3 section
  • your annual report
  • preparing and submitting variations and line extensions
  • responses to questions from the health authorities

We have experience with biologics, small molecules and herbals.

We are familiar with many dosage forms, including tablets, capsules, injections, infusions, creams, patches, suspensions, sprays and inhalations.

We have delivered submissions globally from e.g. the US, EU, UK, China, Russia, Japan, LatAm, ME etc.

What is the result for you and your project?

Our help with CMC documentation should enable you to be regulatory and CMC-compliant with your product documents.

In one word, Arex Advisor is a consultancy which can provide effective support to pharmaceutical and biotech companies with CMC documentation.

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