Regulatory CMC

CMC documentation management

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.

Compliant CMC documentation

There are multiple aspects to consider for your CMC documentation. Below we list a summary of valuable perspectives to keep in mind.

CMC documentation is vital, and keeping a high quality already in early drug development will help you through regulatory submission and to the late post-approval stage.

It must fulfil global regulatory as well as local requirements.

It covers a wide range of activities and describes drug production, testing and control.

Careful planning and evaluation of criticalities may help save time and resources both during development and in the 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

Arex has experience, for example, with biologics, small molecules and herbals.

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

Our team has delivered submissions globally from e.g. the US, EU, UK, China, Russia, Japan, LatAm, ME etc.

More regulatory CMC services

CMC project management
Formulation development and manufacturing advice
CMC strategies
Technical advice and support

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.