Regulis corrects serious non-compliance

Regulis regulatory services team corrects serious non-compliance issue and protects millions of £s of annual sales for pharmaceutical product range.

Situation

Regulis were given the responsibility of providing regulatory services to a pharmaceutical company who had acquired two licensed medicines in a range of formulations and strengths from big pharma. These originator products had EU sales in the millions and Regulis was engaged to provide regulatory support to all the client’s local EU affiliate offices.

Challenge

Regulis soon discovered that there was a significant level of non-compliance between the registered manufacturing and quality documentation and the procedures and specifications applied by the manufacturers. Since there is a legal requirement to manufacture in accordance with the registered information and the manufacturer could not change how they made the products, the company faced the possibility of having their licences suspended and having to stop selling product until such time as the marketing authorisations had been updated. This corrective action would take 6 – 12 months.

Solution

Using our quality and manufacturing knowledge and deep technical regulatory expertise, Regulis designed and implemented a plan to manage the situation.

  • Regulis performed a risk assessment for the quality of the medicines and concluded that patient safety was not adversely affected
  • Regulis defined the changes required and a plan for bringing the licences into compliance
  • Regulis proactively initiated communication with scientific staff at the competent authority to gain their agreement that the products could remain on the market
  • Regulis executed the plan, corrected the licences and delivered a compliant situation.

Benefits

The Regulis regulatory services engagement delivered:

  • Full manufacturing and registration documentation compliance
  • The protection of the existing sales of millions of £s
  • Protection of the client’s reputation in the eyes of regulatory authorities in the EU
  • Continued product sales.

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