IDE® Pharmaceutical Consultancy Bioequivalence Studies, Regulatory Affairs and Scientific Consultancy for Pharmaceutical and Medical Industries
IDE® Pharmaceutical Consultancy is a contract research organisation (CRO) that provides consultancy and contract research services for the pharmaceutical sector.
With a rich legacy of experience and expertise, we have partnered with life sciences companies to achieve their desired results in clinical development and regulatory affairs, delivering outcomes through quality bioavailability / bioequivalence studies beyond regulatory, toxicology and scientific consulting expertise for the pharmaceutical industry.
Regulatory affairs services for pharmaceutical applications
IDE carries full programme national regulatory guidance and support in Turkey through the creation and implementation of a strategic integrated product development plan and regulatory management throughout the entire product lifecycle [including common technical document (CTD) and variation dossiers preparation].
We also offer regulatory strategy and agency communication to obtain first-cycle approvals, food supplement and medical device registration.
Furthermore, we provide attendance to good manufacturing practice (GMP) inspection and Marketing Authorisation Holdership on behalf of companies, as well as Compassionate Use Programme and patient basis submissions and due diligence activities and regulatory legal advice on pharmaceutical affairs.
Bioequivalence, bioavailability and clinical trials services
IDE conducts bioequivalence (BE) studies and provides related medical writing and regulatory support. We have experts for BE studies in collaboration with the sponsor and selected clinical and bioanalytical centres.
Our research team specialises in clinical biochemistry, bioanalytical method development, bioanalysis and statistical evaluation, with additional experience in regulatory issues and approval, logistics and time management.
We provide services in this field including protocol writing, preparation of clinical trial application dossiers, submission to the Agency and the Ethical Committee, insurance contracting and sample labelling. We also help with recruiting and associated documentation, clinical analysis and contracting of the clinical centre, previously audited and certified by European and US Authorities.
IDE also monitors clinical centres during studies and analyses biological samples in internationally accredited centres, pharmacokinetics (PK) calculations, statistics and bioanalytical reports and final study reports, while providing scientific advice on BE / BA studies and Biowaiver Dossier Preparation.
Registration-specific documents preparation and toxicology services (ERA, PDE, ADE, OEL Reports)
We offer advice on compiling numerous reports such as scientific writing expert report Module 2.3 / 2.4 / 2.5, Environmental Risk Assessment (ERA) Report, GMP and marketing authorisation prioritisation report and price application dossiers.
Furthermore, we provide toxicology services, which include Permitted Daily Exposure (PDE) / Acceptable Daily Exposure (ADE) Toxicology Reports, offering approximately 1,800 PDE / ADE reports at our clients’ convenience, as well as Occupational Exposure Limits (OEL) Reports and cosmetic product safety assessment reports.
IDE is one of Turkey’s first specialised CRO, with 21 years of experience. Our company adheres to confidentiality, as well as current guidelines and regulations of national and international Health Authorities under complete Confidentiality Agreement, European General Data Protection Regulation (GDPR) and Turkish Personal Data Protection Law (KVKK).
We are located next to the Turkish Medicines and Medical Devices Agency in the Business Centre of Ankara, performing services and both local and international levels.