Regulatory Affairs Consulting.

Get your products to market without delay with Consulting from Entourage.


Meet all requirements for approvals.


Meet all points along the regulatory lifecycle.


Be ready for regulatory inspections at any time.

Regulatory Affairs Consulting needed?

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Compile all necessary information for CTD dossier amendment and be ready for regulatory inspections targeting pharmacovigilance.

Medical Devices.

Register and certify MD and IVD products while collecting all information on clinical evaluation, post-market surveillance and vigilance of products.

Regulatory Affairs Consulting needed?

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Apply regulatory strategy.

To successfully meet regulatory requirements and avoid penalties, rejections, and delays, life sciences companies must be aware of the challenges posed by different laws in different market regions. Maintain quality and confidence with solutions from Entourage.

How we can support you with Regulatory Affairs Consulting.

What you need to know about Regulatory Affairs Consulting.

What is Regulatory Affairs?
The regulatory affairs manager profession has evolved from the desire of governments to protect public health by controlling the safety and efficacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and the desire of companies responsible for discovering, testing, manufacturing and marketing these products to ensure that they deliver products that are safe and make a valuable contribution to public health and welfare.

Regulatory experts are responsible for:

  • Keeping track of the constantly changing legislation in all regions where a company wants to distribute its products
  • Advice on legal and scientific restrictions and requirements
  • Collecting, collating and evaluating scientific data
  • Submitting registration dossiers to the regulatory authorities and conducting the necessary negotiations to obtain or maintain the authorisation for the products concerned
  • Strategic and technical advice at the highest corporate level, making an important contribution to the success of a development programme and the company from both an economic and scientific perspective
  • Helping the company avoid problems caused by poorly kept records, inadequate scientific thinking or poor presentation of data.
  • In addition, the regulatory department is often involved in the development of product marketing concepts and usually has to approve packaging and advertising before they are used commercially.