Regulatory affairs

Public authorities and other regulatory authorities try to protect public health to the best of their abilities. They realise this by painstakingly following the safety and efficiency of the products in the life science sector. Regulatory affairs is the professional field which ensures that products comply with valid regulations and legal requirements.

Are you interested in support and advice related to your regulatory affairs? The Pauwels Consulting regulatory affairs managers and consultants have extensive experience in the field of audits, regulatory strategies, authorisation applications and interaction with the authorities. We would be pleased to assist you during all important phases within regulatory affairs, from the early preregistration phase up to authorisation applications.

Regulatory affairs in practice

Pharmaceutical companies must observe strict rules and guidelines set by the public authorities and other authorities during all phases of product development to ensure the safety and effectiveness of their products for patients.

Within this strictly regulated environment, regulatory affairs play an essential role:

  • as a link between the company and the health authorities involved;
  • as a link between the various divisions within the company;
  • but also as a leading authority to provide strategic advice regarding extremely complex decisions during the life cycle of each product.

For this reason, regulatory affairs managers are continuously working together with the authorities and the various divisions within their company to ensure complying with the legal obligations as set by the health authorities.

The division Regulatory affairs also ensures obtaining and maintaining the marketing authorisations and controls activities, such as broadening the indication of medicine, changes of the formulation, changes in dosage, etc.

Regulatory Affairs - Advies en ondersteuning - Pauwels Consulting

Challenges related to regulatory affairs

The main challenge within each regulatory affairs system is the set-up of a solid, analytically driven strategy which is supported by the total organisation. Organisations which do not prioritise targeted and transparent strategic actions will not stand any chance when dealing with regulatory authorities.

Successful observance of the valid regulations, which are becoming increasingly more strict, requires a systemic thinking process and a systematic approach, based on the effective use of strategic insight, group mobilisation and cooperation with the public authorities, lobby groups and regulators.

Furthermore, regulations within the pharmaceutical sector are continuously changing due to harmonisation, safety and security issues, globalisation and acquisitions. Pharmaceutical companies must make a constant effort to closely follow these changes and to reorganise in a flexible manner if they are expected to do so.

Regulatory affairs at Pauwels Consulting

Are you interested in support and advice related to your regulatory affairs? Our regulatory affairs managers have experience in the field of national and global registration and authorisation applications and the follow-up of all related activities after submission. They would be pleased to assist you with:

  • the development of regulatory strategies for product life cycles;
  • the preparation and presentation of dossiers;
  • the evaluation, archiving, preparation, revision and submission of authorisation applications;
  • the improvement of the interaction with the authorities.

Our regulatory affairs managers ensure that all your dossiers, registrations and authorisations are submitted in time and that all safety-related changes are implemented in time. Furthermore, they ensure that all projects will progress in accordance with the valid SOPs and guidelines.

They are accustomed to working in teams and to closely interacting with and consulting other divisions, including colleagues from the divisions Business development, Regulatory science, Pharmacovigilance, Product launch, Artwork, Supply chain and Quality, to ensure conformity on the level of your organisation.

Would you like to have more information?

Are you interested in support and advice related to your regulatory affairs? Do not hesitate and contact us, without any obligations.

Our regulatory affairs managers and consultants would be pleased to assist you as from the early preregistration phase up to authorisation applications.