Clinical Trials

Members of our team with expertise in regulatory requirements for Turkey in which you want to start the clinical trial will provide you with the list of documents required, specific country regulations and timelines for submissions and approval. Starting from contract negotiations, translation requirements and compilation of submission files, we will ensure proper submission with complete and quality documentation.

Audit and compliance activities for cGCP, cGLP and cGMP

Our expert auditors perform a diverse range of audits including cGLP, cGMPand Quality Systems audits. We also perform independent, third-party audits for compliance with cGCP, an indispensable element to any successful drug discovery and development process. Our auditors will assist you in developing and implementing an audit action plan that addresses your specific needs.

Procurement of Reference Products

In the event of Reference Product selection and procurement IDEAL Pharma Consulting gives the following services:

·         Determination of relevant reference products

·         Searching and determining the price of relevant reference products on the markets of USA and EU countries.

·         Procurement/Delivery of reference products

Regulatory Submissions and e-submissions

As IDEAL Pharma Consulting we understand the critical importance of complete and accurate regulatory submissions and collaborate on submission planning and preparation. We perform in accordance with EMA (European Union) and US-FDA guidelines critical writing and pre-submission reviews of key technical documents to ensure consistency, scientific accuracy, completeness, and regulatory compliance.

Training Services