Formulation development and manufacturing advice to Services in regulatory affairs

If you are developing a medicine for future commercialization, formulation is something that you will consider early on. A carefully selected formulation will help you:

  • ensure sufficient bioavailability
  • optimize 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)

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?

Why use our support with formulation strategy?

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 jeopardizing 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 life cycle (see Commercial Production Support and Advice)

What is the result for you and your project?

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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