Contact

Search…

Industry Sectors

Regulink provides specialist consulting and support services in all areas of regulatory affairs, CMC, pharmacovigilance and project/programme management to the life sciences industry. We have a broad team with relevant experience in the key sectors of this diverse industry.

Learn more about how Regulink can support its clients in each of these sectors.

Pharmaceuticals and Generics

The landscape for the pharmaceutical industry is radically changing. A focus on value and budget control, set against the implications of a changing and ageing patient population with an increase in chronic conditions and huge R&D costs has led industry to an increased consideration for lifecycle management to sustain revenues and improve margins.

Regulink can help the pharmaceutical industry to successfully maximise its assets, by traditional LCM strategies, e.g. new formulations or patent extensions, to line extensions of products, acquisitions, generic opportunities, and also licence maintenance and outsourcing activities.

Consumer Healthcare

Consumer Healthcare products are wide ranging and include OTC medicines such as herbals, cosmetics and nutraceuticals (vitamins and supplements). Within this sector are globally recognisable brands available without medical prescription in pharmacies and supermarkets, either by pharmacist control or by self-selection.

The increased awareness of consumers to the treatment of minor conditions, through both education as well as promotion, has led to the expansion of the Consumer Healthcare sector. OTC medicines comprise well-established active ingredients with well-known effects in large numbers of the population, over a long period of time (decades). Irrespective of this perceived safety, these products do not have reduced regulatory and quality control burden.

Veterinary

The controls on the manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines in the EU is set out in the Veterinary Medicinal Products Directive 2001/82/EC (as amended), which is the basis for UK controls, nationally enshrined in the Veterinary Medicines Regulations (VMR).

Regulink has a deep understanding of the regulatory landscape for veterinary medicinal products from experience of its core team in two of the leading Animal Health companies in the UK.

Traditional Herbal Medicines

Following the introduction of the European Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC on 30 April 2011, which mandated the implementation of traditional herbal registration schemes within the EU member states for those herbal medicines suitable for use without medical supervision, there has been need for manufacturers to obtain either a full MA based on the safety, quality and efficacy of the product, or a traditional herbal registration (THR) based on the safety, quality and evidence of traditional use of the product.

Regulink has hands-on experience in these registration procedures and can assist with provision of expert advice and guidance in the preparation of THRs or MAs.

Cosmetics

In many cases, cosmetics regulations is seen as an area outside of the standard Regulatory Affairs arena, however it plays an important part in a large percentage of commonly available consumer products. Understanding the key differences between cosmetics and their more regulated medicinal cousins and how to support commercial teams in their goals is key to cost effective and professional support.

Nutraceuticals

Nutraceuticals are a rapidly emerging sector of the Healthcare industry. This may be attributed to dissatisfaction of consumers with rising drug costs and the conventional marketed remedies, but also possibly the perception that being naturally-derived is a better and safer alternative. These products are foods or food ingredients that may provide health and medical benefit, ranging from dietary supplements and isolated ingredients to processed foods and beverages, where a physiological effect is claimed.

Nutraceuticals must comply with European and national food safety regulations, together with codes of practice that stipulate procedures for safe marketing and guidance for related product information.

Medical Devices

Medical Devices legislation has recently gone through quite an overhaul, with the release of the Medical Devices Regulation and in vitro Diagnostic Medical Devices Regulation. With the addition of new rules for the United Kingdom, it is important for Medical Devices manufacturers and importers to work with experienced regulatory devices professionals. Over the years, Regulink has specialised in ‘grey area’ devices such as borderline products and combination device/medicine products as well as true devices.

×

Please sign up with your details below

"*" indicates required fields

Consent*