Good manufacturing practice (GMP) support

Commercial production support and advice

In general, our assistance will result in a thorough evaluation of the manufacturing and control process, potentially simplifying or improving it to reduce costs or bolster robustness. The combination of our experience with formulation strategy, quality assurance and regulatory affairs will be of use to you at any stage of the development or commercialisation journey.

Optimising time to market

Taking a drug product from development into commercial production is a fantastic achievement. Now, every hour is of importance in terms of reaching the final goal: entering the pharmaceutical market.

With a carefully planned regulatory strategy it may be possible to save time in your final preparations.

Several functions will need to be involved to ensure the most efficient and sustainable solutions, including quality assurance, GMP, regulatory affairs etc.

You could need support with things that are challenging in terms of time, costs and human resources:

Validation planning

Timing of validation batches

Bracketing design

Why use our support with commercial production?

Arex Advisor can do the following:

– Offer advice on how to structure your variation application
– Plan potential studies
– Write the technical documentation
– Submit the eCTD files
– Help with changes to manufacturing processes such as scale-up, tech-transfer, changes to in-process controls and specification limits

To reduce your risks, we can arrange more opportunities for communication with the health authorities, for example through scientific or regulatory advice meetings etc.

More good manufacturing practice (GMP) support services

Acting Qualified Person (QP)
GMP responsibilities for MA holders
Quality assurance and GMP compliance
Quality control and batch evaluation
Technology transfer support and advice

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.