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.
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
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.
Acting Qualified Person (QP)
Auditing
GMP responsibilities for MA holders
Quality assurance and GMP compliance
Quality control and batch evaluation
Technology transfer support and advice
Erik Hedner
Arex Advisor AB
Contact us
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.