Ann Godsell Regulatory

We can offer regulatory support for any aspect of regulatory projects throughout the lifecycle of a pharmaceutical from the early development stages through to supporting established brands on the market.

Our range of pharmaceutical regulatory services / training includes the management and preparation of regulatory submissions for both clinical trials and marketing authorisation applications, and post-licensing regulatory support.

Many years of experience assures high quality regulatory consultancy is available.

We have extensive experience of the pharmaceutical and allied industries, and a comprehensive understanding of the ever-changing regulatory environment. We are not daunted by new challenges brought by developing legislation.

Particular areas of expertise:

Pharmaceutical Regulatory Consulting

Early in a product lifecycle when a pharmaceutical is ready for testing in man, clinical trial applications must be submitted and approved by a Health Authority in the EU country before the trial commences. We can provide pharmaceutical regulatory consulting services for subsequent changes in the protocol and obtain the necessary approvals for such changes, such as substantial clinical trial amendments.

When all the data required to prove quality, safety and efficacy of a product has been generated a marketing authorisation submission can be made (by the Decentralised, Centralised or Mutual Recognition procedure).

We can advise on data requirements for clinical trial and marketing authorisation applications.

We can assist with the writing, compiling, or actual submission of an application.

PSURs

Regulatory maintenance work, e.g. variations and Periodic Safety Update Reports (PSURs), is required in order to keep a marketing authorisation current. Changes to quality or clinical issues must be made by variation, such as manufacturing site changes or additional contraindications, and must be approved by a Health Authority. Periodic safety update reports (PSUR’s) must be provided to the Health Authority on an ongoing basis.

Herbal Medicines Registration

Any new herbal products on the market must be registered under the traditional herbal medicines registration scheme in accordance with EU Directive 2004/24/EC if the product makes any medicinal claim.

We offer particular expertise in projects to gain registration of traditional herbal medicines. Data is required that provides proof of safety, efficacy and traditional use. A product, or comparable one, must have been in use in within the EU for the last 15 years and have at least 30 years overall established usage.

Training in Regulatory Affairs

We offer all aspects of training in regulatory affairs customised either as one-to-one tailored training, small groups or small seminars. 

A mentoring service is available to developing departments or individuals to allow them to learn on the job with real life work projects to complete.

Regulatory Consultancy for Mergers, Acquisitions or In-licensing

We offer regulatory consultancy on strategy for companies who are considering a merger or acquisition. We can carry out due diligence activities for acquisitions or licensing opportunities.

Contract Regulatory Support

We offer contract regulatory support either on your company site or remotely. Contracts can be for example for particular projects or for particularly periods of time.

Food Supplements and Borderline Products

EU Directive 2002/46/EU is the legislation that controls food supplements containing vitamins and minerals. In future it may be further extended to include “botanicals”.

It is difficult to distinguish sometimes if a product would be a medicine, food or cosmetic. Different legislative requirements govern each category and it is essential to correctly determine the status of a borderline product.

Medicine Patient Information Leaflets

Any medicine patient information leaflet accompanying a medicine must be written in a specified format. It must pass readability testing (known as “user testing”) in order to prove it can be understood.

We have much experience in the writing and testing of patient information leaflets which comply with all the necessary requirements. Leaflets must be written in a balanced manner so they contain all the necessary statutory information required, but at the same time are easy for users to understand. This is to ensure that the medicine is used safely and effectively by patients.