Trac Services | What is regulatory affairs?
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What is Regulatory Affairs?

The consultancy for global, pharmaceutical regulatory affairs

Regulatory affairs is a profession within regulated industries such as pharmaceuticals, energy, banking and telecoms. It has developed from the stated aim of governments to protect, e.g. public health through pharmaceutical regulatory affairs, which is TRAC’s professional specialism.

Broadly speaking, pharmaceutical regulatory affairs covers the following areas:

  • Compliance – ensuring that all relevant regulations and laws are met, and due processes followed.
  • Consultancy – advising on how the regulatory and wider socio-economic climate affects proposed activities
  • Collaboration – working with regional, state and local regulatory agencies and bodies, e.g. European Medicines Agency.
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PHARMACEUTICAL REGULATORY AFFAIRS

The regulatory affairs function within the pharmaceutical and healthcare industries is vital in making high quality, safe and effective medicines and healthcare products available worldwide.

The pharmaceutical regulatory affairs professional’s roles and responsibilities span all elements and stages of the drug development process including research and development, clinical trials, premarket approvals, manufacturing, labelling and advertising, and post market surveillance.

It can take up to 15 years to launch a new medicinal product and regulatory affairs professionals, such as our dedicated experts at TRAC, will contribute and add value throughout the process.

TYPICAL ACTIVITIES

The nature of the work we undertake is very varied.  Below are some of the activities our regulatory experts may carry out on behalf of our clients:

  • ensuring that a company’s products comply with the relevant regulations in the countries where the product is sold or is planned to be marketed;
  • keeping abreast of international legislation, guidelines and customer practices in all countries;
  • collecting, collating and evaluating scientific data that has been researched by pharmaceutical and healthcare companies;
  • preparing submissions of licence variations and renewals to strict deadlines;
  • writing clear, accessible product labels and patient information leaflets;
  • planning and developing product trials and interpreting trial data;
  • advising scientists and manufacturers on regulatory requirements;
  • providing strategic advice throughout the development of a new product;
  • reviewing company practices and providing advice on changes to systems;
  • liaising with, and making presentations to, regulatory authorities;
  • negotiating with regulatory authorities for marketing authorisation;
  • specifying storage, labelling and packaging requirements

In this way we help companies avoid the problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

REGULATORY PROFESSIONALS

Regulatory affairs professionals come from a number of diverse backgrounds. Our dedicated experts all have a bachelor’s degree in a scientific field and many have an advanced degree.

In addition they possess valuable skills such as project management and organisation, negotiation and communication, and the ability to learn from the experience of others.

On-going education and continuing professional development are critical to the regulatory professional.  Regulatory professionals must keep up to date with regulatory policies and procedures on a global level, as well as maintain an understanding of the scientific and technical background of healthcare products.

TRAC is fully committed to the training and development of our staff and we work closely with our professional body TOPRA – The Organisation for Professionals in Regulatory Affairs.  This means that our team of experts is always at the forefront of new developments within the industry.  We also support TOPRA in attracting new people into the industry to meet the growing demand for regulatory affairs professionals.

We hope you now have a better understanding of what TRAC does and the important role we play in ensuring everyone has access to high quality, safe and effective medicines wherever they are.

If you have any further questions about TRAC’s consultancy services or would like to find out more about working with us, get in touch.

Find out how our dedicated regulatory experts can help you