In recent years, the industry has witnessed significant changes in the legislation pertaining to the manufacture, distribution and supply of chemicals globally. It is crucial to understand the nature of this evolving set of regulations. A comprehensive understanding of all legislation relating to the manufacture, distribution, use, treatment and disposal of chemicals is vital to comply with the regulations. At GTI, our global network of experts experienced in the regulatory domain ensures chemical compliance across all phases of our products’ life cycle.

• Persistently stay compliant as regulations continue to change
• Navigate guidelines that vary widely across different states and countries
• Find solutions to ensure accurate and sustained global regulatory compliance

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is adopted to improve the protection of human health and the environment from the risks posed by chemicals. It also aims to enhance the competitiveness of the global chemicals industry. A new global norm is to ensure that all the chemicals managed are as per REACH regulations stipulated by regional authorities.

As per REACH, GTI adheres to the following region’s compliance.

EU REACH | K REACH | Turkey KKDIK | UK REACH

Our Pharma Actives team is experienced and well trained in regulatory and quality global standards stipulated by various agencies like FDA, EMEA, CDSCO, WHO etc. It is also proficient in managing various cGMP regulatory standards mandated by regulatory agencies like US FDA 21 CFR 210 and 21 CFR 211, EU GMP Annex II, Schedule M, ICH Q7A, WHO GMP etc.

We extend our knowledge about global and local regulations to our clients. Our team offers end-to-end support on regulatory submissions to our clients and collaborates with them to move forward together.

DMF Filings Details: Under preparation