Regulatory affairs

The regulatory affairs services provided by our company are applicable to many different product types, including human medicinal products, medical devices, food supplements, homeopathic drugs, veterinary medicinal products and herbal products.

We understand the varying regulatory requirements and we can help you prepare, complete and submit the documents ensuring they meet all local regulatory needs.

Our dedicate experts tailor your project to meet the regulatory requirements in Central Europe.

Our team understands the importance of the highest quality regulatory submission. We will work with you to prepare and complete submissions and communicate interact and liaise with state authorities to ensure approval on time.

Services

Readability User Testing

  • Comparison of Summaries of Product Characteristics for MRP
  • European regulatory strategy
  • Labelling and Mock ups
  • Marketing and Authorisation Applications – National, Decentralised and MRP as CMS or RMS
  • Post-marketing activities – product maintenance – renewal , variation
  • Preparation of Module I according to the local requirements
  • Preparation of Module II
  • Reformatting the MODULE III in the old NTA to the new CTD

Pricing and reimbursement strategy

  • Pricing assessment
  • Public policy assessment
  • Reimbursement negotiation strategy

Advertising, marketing and PR activities

  • Ensure graphics design of Ad
  • Market access support
  • Opinions leaders for launching your products

Strategic advice

Selection of Czech pharma-market according to potential – to find possible new target market from a current portfolio Ensure market access of your products at the earliest possible time Developing and determination strategy if your products fall to Rx, OTC, Non-pharmacy outlets products or Food supplements

Food supplements and Nutriment

Ensure a market access and cooperation with the responsible authorities

Pharmacovigilance

Ensure report of ADR

Others

Expert witness in litigation cases

Professional, confidential experienced

  • Our aim is to provide the highest standard in the quality of our services and we guarantee reliability.
  • Confidentiality and security of our client’s data can be assured and, as an independent company there is no conflict of interest.
  • We welcome enquiries for projects from all companies.
  • Estimates are provided entirely free and without obligation and can be sent out within 2-3 days of receiving the clientś brief and copies of documentation.
  • Work is undertaken either on a project basis against a formal estimate or an hourly basis for general consultancy work.
  • Once the project has started, we like to keep clients fully informed of progress with the project and with cost.