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.
DetaylarOur 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.
DetaylarIn 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
Detaylar
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.
Detaylar·
Sector-specific
professional and scientific training programs
·
Scientific seminars
and in-house training activities
·
In-house personal
development training