Regulatory CMC

Formulation advice and support

Working with us you will maintain a holistic view of all aspects of chemistry, manufacturing and control, while keeping the patient and treatment in focus.

You will make savings in time and cost with our help by justifying which studies and specification criteria are required, and which may be omitted.

Overall, this will help ensure that the right formulation and manufacturing process is selected, and that CMC and regulatory requirements are fulfilled.

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Strategic formulation for medicinal development

If you are developing a medicine for future commercialisation, formulation is something that you will consider early on.

A carefully selected formulation will help you:

  • Ensure sufficient bioavailability
  • Optimise patient compliance
  • Achieve sufficient shelf-life
  • Manufacture cost-efficiently
  • Gain competitive advantages (in case you have a super generic – and potential possibilities for patent protection)
  • Reduce both risks and costs for commercial production
  • Enable you to reach your Target Product Profile, while preparing for a successful scale-up process and cost-efficient manufacturing
  • Understand your product’s critical quality attributes (CQA)

Questions to ask

The needs of the patient are just as important. Ask yourself the questions:

Is the treatment associated with difficulties in swallowing?

Is an instant effect desired?

Does the substance have an unpleasant taste that could affect compliance?

Could the visual recognition of the dosage form be improved?

Could we reduce the number of daily doses to boost compliance?

Will the manufacturing process be cost efficient?

Why use our support with formulation?

Our consultants are experienced in working with various pharmaceutical formats such as tablets, solutions, gels and capsules, and various routes of administration, such as oral, oromucosal, nasal, pulmonary and topical – from development to scale-up and commercial production.

We can support you with:

– Risk evaluation to find possibilities for simplification without jeopardising the patient’s safety
– Perform knowledge and risk assessment when reading and challenging the ICH guidelines
– Design a careful registration strategy ensure and maintain compliance and a sustainable process for manufacturing and control throughout the product lifecycle.

More regulatory CMC services

CMC documentation management
CMC project management
CMC strategies
Technical support and advice

Your contact person

Erik Hedner

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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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.