Regulatory Affairs
From the beginning of your project to its completion our regulatory affairs team will provide overall regulatory support for your clinical trial as a part of our comprehensive clinical study management services.
Depending on our client's needs we also offer qualified consultant services to assist you step by step through any regulatory process or concern. We review your study documents, such as study protocols, drug labels, patient informed consent forms and information sheets, to make sure they have been prepared according to all applicable laws and regulations in the corresponding country.
CONET's regulatory affairs team offers comprehensive service for clinical trials conducted in Western and Eastern Europe
Even though CEE countries (Central and Eastern European Countries) are working according to European regulations, some countries have their own specific additional requirements. Our regulatory affairs team has acquired expertise and insight to the local requirements and regulations and has developed productive relationships with local competent authorities. We understand the country specific particularities regarding submission strategies and effective follow-up with competent authorities throughout Europe.
Regulatory strategy consultation
- Review of study submission documents to ensure they will meet the regulatory requirements in the appropriate country
- Processing subject insurance and also local insurance policies, if required (e.g. in Russia)
- CTA (Clinical Trial Application) preparation, submission and management
- Ongoing interaction with regulatory authorities, Ethics Committees and other governing bodies, where required
- Certified translations and back-translations of documents into applicable languages (provided by our partner www.medax.de) and proofreading by native speakers
- Procurement and management of import and export licenses for IMP and study material, customs administration, if required (for more information see also Clinical Logistics Services)
- Tracking and updating of regulatory documentation
- Processing of protocol amendments and revisions to patient informed consent forms and information sheets
We have the contacts and the know-how to process your submissions and communications with regulatory authorities throughout Europe. Due to our extensive experience, accurate and efficient submissions are executed, preventing costly delays.
CONET also offers special service for special situations. Our Quality Assurance group helps to prepare audits and inspections. In the event the operations of your clinical trial do not meet your expectations we are ready to offer our Clinical Trial Rescue Services.
