Regulatory-Relevant

Extensive preclinical and clinical trials are required for successful drug approval by national and international authorities such as the FDA, EMA , or TİTCK . Our laboratories provide all necessary analytical services to meet regulatory requirements – from early development phases through to submission.

Our Scope of Work

• Preclinical Phase (GLP Logo)
  o In-vitro Tests
  o In-vivo Studies
  o Toxicological Studies
  o Pharmacokinetic and Pharmacodynamic Tests
  o Chemical Tests

Tests for the preclinical phases are conducted in our laboratory.
• Clinical Phase (GCP Logo)
  o Phase I Studies
  o Phase II Studies
  o Phase III Studies

Bioanalytical investigations for all clinical phases are performed in our laboratory.
• Regulatory Submission (FDA, EMA, TİTCK Logos)
• Applications are submitted to institutions such as FDA, EMA, TİTCK, etc.

Clinical Phase (GCP-compliant)

We support you with the approval of your pharmaceutical product in various markets. Our services include:

• Preparation of required documentation for FDA, EMA, TİTCK, and other authorities
• Analytical evidence, study reports, and dossier compilation
• Support for regulatory authority communication and review processes

Marketing Authorization Application & Submission

These tests investigate the potential toxic effects of a medical device on the entire organism. They assess acute (short-term), subchronic (medium- to long-term), and chronic (long-term) toxicity. The objective is to rule out systemic risks such as organ damage, metabolic disorders, or other health impairments.

Our Process

Our experienced team provides comprehensive support for all testing phases, based on ICH, GLP, GCP guidelines and the requirements of international regulatory authorities. With state-of-the-art technology, validated methods, and regulatory expertise, we ensure that your product achieves market authorization quickly and safely.