Consistency with global application procedures
It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and their extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions. Marketing authorisations for medicinal products are subject to very strict overall requirements. Preparing, submitting, and maintaining CTD/eCTD dossiers places considerable demands on a company’s human resources.
Our services include
Product Literature and Readability Testing
Good quality product literature is one of the keys to successful regulatory approval and attention to detail is important in writing the Summaries of Product Characteristics, Patient Information Leaflets and labelling texts. RegPak BioPharma Consulting can advise on the regulatory requirements for both content and format under EU or non-EU legislation as well as write or review the relevant texts. Leaflets intended for the patient must be written in plain English and there is now a requirement in Europe for these to be user tested to ensure readability. RegPak BioPharma Consulting can arrange a full readability testing service and can prepare test reports suitable for submission.
NUTRITIONAL & FOOD SUPPLEMENT
We provide comprehensive scientific, technical, regulatory, legal, and project management services Nutraceuticals are food or food ingredients that have defined physiological effects. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, “optimal nutrition” the concept of enhanced performance – both physically and mentally – and reduction of disease risk factors. On the other hand, a dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supply nutrients, such as vitamins, minerals, fatty acids or amino acids, that are missing or are not consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs. RegPak BioPharma Consulting provides expert opinion and advice in the areas of technology evaluation / due diligence in nutraceuticals and food supplement product approval. We perform a comprehensive document review and prepare a written opinion as to the potential for success for the approach (es). Our services include:
COSMETICS
Cosmetic products are topical products that are not classified as a medicinal product. Cosmetic products are also important consumer products: apart from "traditional" cosmetic products, such as make-up and perfumes, it also includes products for personal hygiene, for example tooth-care products, shampoos and soaps. There is a main regulatory framework which aims at ensuring the free circulation of cosmetic products in the internal market and safeguarding the safety of cosmetic products placed on the EU-market. RegPak BioPharma Consulting can assist you in bringing your cosmetic products, including products with therapeutic value, to the market shelf by: