Know About Us
We Offer End-To-End Compliance Service Solutions For A Vast Variety Of Services Across 50+ Countries And 75+ Regulations. We Have 15+ Years Of Experience In Generating, Managing And Monitoring Extensive Amounts Of Studies For 1000+ Lead Registrations.
Sectors
At GPC Gateway, We Serve A Diverse Range Of Sectors To Address Their Regulatory Compliance And Chemical Management Needs. Our Expertise Spans Industries Such As Agriculture, Circular Economy, Cosmetic, Food Contact Material And Medical Devices . We Provide Tailored Regulatory Intelligence Services To Ensure Compliance With International Chemical Regulations, Facilitating Smooth Market Entry And Ongoing Operations.
We Have Conducted Pharmaceutical And Vaccine Testing Encompassing A Diverse Array Of Tests. The Emphasis Has Been On Biologicals, Aligning Closely With Global Guidelines And International Pharmacopeia Standards (ICH, USP, IP) To Secure Market Approvals Worldwide. The Studies Caters To IND, ANDA, And NDA Submissions/Filings, Tailored To The Needs Of Both Biotech And Pharma Industries.
Drawing Expertise From Analytical Chemistry, In-Vitro And Genetic Toxicology, And In-Vivo Toxicology, Our Team Is Dedicated To Offering Development Services Aligned With OECD, OCSPP (Formerly OPPTS), And Other Relevant International Guidelines In The Field Of Toxicology. Our Focus Encompasses Crucial Studies That Underpin Approved New Drug Applications For The US FDA. These Studies Involve A Comprehensive Battery Of Animal Tests Assessing Acute Systemic Toxicity Through Three Exposure Routes, As Well As Examining Skin And Eye Irritation/Corrosion And Skin Sensitization.
Supporting a diverse range of chemical industries, we incorporate testing for dyes, adhesives, paints, glues & favicons, solvents, inks, plastics, and various other products. Our capabilities extend to providing a comprehensive set of regulatory studies for New Product Registrations. We possesses well-established expertise in REACH (Registration, Evaluation and Authorization of Chemicals), the EC1907/2006 Regulation that supersedes all prior legislation on chemical authorization in the European Union (EU). We have tailored a specific suite of services, including Physicochemical, Toxicology, and analytical services, to assist companies in expediting their registrations, generating essential Use, Risk, and Hazard data for a multitude of products.
we offer diverse in-vitro testing and safety assessments using alternative animal models for cosmetics in accordance with regulatory agency requirements. Recognizing the increasing demand for non-animal models, we provide a range of cosmetic testing services following OECD guidelines.
In accordance with client specifications, we offer medical device services that adhere to the ISO 10993 guidelines and other relevant international guidelines.
Services
At GPC Gateway, We Serve A Diverse Range Of Sectors To Address Their Regulatory Compliance And Chemical Management Needs. Our Expertise Spans Industries Such As Agriculture, Circular Economy, Cosmetic, Food Contact Material And Medical Devices . We Provide Tailored Regulatory Intelligence Services To Ensure Compliance With International Chemical Regulations, Facilitating Smooth Market Entry And Ongoing Operations.
We offer assistance for drug discovery and development action by orchestrating and executing a range...
We offer a variety of services within both GLP and Non-GLP settings encompassing fields such as anal...
Adopting an integrated strategy, we provide comprehensive safety assessments essential for Investiga...
We have the capacity to perform analyses such as soil characterization, residue testing, environment...
Please be aware that apart from the oral route investigations mentioned, a diverse range of customiz...
Provides an extensive set of assessments for impurity qualification, covering genotoxicity and syste...
Our in vivo capabilities span a wide range of pharmacological testing areas. We offer safety pharmac...
We have the capacity to perform comprehensive Physicochemical properties testing across multiple sec...
