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Life Sciences Consulting
Contact:
Email:
Tel:
+1 (832) 977-6623
Address:
14090 Southwest Freeway, Suite 310, Sugar Land, TX 77478
About Us:
We are a life science consulting company. Our services are built on a foundation of many years of experience in providing high standard, well received and continually improved pharmaceutical validation, project management, material qualifications and supply chain management.
Our founder is an experienced Mechanical Engineer that has worked with complex Airhandlers, HVAC systems, biocontainment and other Facilities, Utilities and Equipment (FUE) Qualifications.
Our team has experienced Chemical Engineers with hands on work experience in Qualifying Freezers, refrigerators, cold rooms, warehouses using Kaye Validators and Data loggers. We have qualified multiple computerized equipments like MES, ERP systems, BMS and EMS using 21CFR Part 11, 21CFR Part 820, ICH Q7 and GAMP 5 regulations.
We work with CGMP facilties across the world and have expertise in GXP, GCP AND GDP regulations. We were involved in distributing hand sanitizers throughout the USA region where we were involved in multiple facility auditing according to CGMP regulations, packaging and labelling validations.
We are ISO 9001 and ISO 14001 Certified.
Our Services:
TMC offers global pharmaceutical and biotech talent solutions in addition to our world class finest quality pharmaceutical materials using our best in class supply chain experience.
We are your one stop regulatory compliance solution.
Based on deep expertise acquired over many years and rich experience gained in a variety of validation projects, TMC offers efficient validation services that include development of validation strategies and plans, creation and execution of IQ/OQ/PQ scripts, documentation of test results, design of traceability matrices, and delivery of a comprehensive summary report.
Resources:
We provide a comprehensive validation training solutions to companies and individuals.
Mani Palani
President
Mani Palani is the President and Founder of Texan Minerals and Chemicals LLC. He began the company in 2006 and has built it into one of the top supply chain companies of various global commodities. Palani is a firm believer in diversity and relying on meritorious multi-ethnic workforce.
Mr. Palani has more than 20 years of complex engineering experience, including energy supply and efficiency, cost effective renewable energy projects, and sustainability.
While searching for competitive solutions in addressing the critical needs of energy security and sustainable product, Mr. Palani developed a global marketing and supply chain strategy tackling complex import and export process covering a broad range of issues, such as recycling, legal mining of raw product, rare earth minerals, and advanced technology products and solutions.
Mr. Palani is a licensed Professional Engineer in Texas and earned his engineering education at Indian Institute of Technology and Institution of Engineers in India. He also attended a PhD program in Mechanical Engineering at Texas A&M University. Mr. Palani has also made numerous contributions to several publications pertaining to energy efficiency, ventilation, and renewable energy.
TMC Experience with FDA OTC Drug Product Development and Compliance
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FDA OTC Drug Registration: TMC ensured compliance with FDA regulations by obtaining OTC Drug Registration, which was crucial for the legitimacy and market acceptance of OTC drug, communicating with FDA eDRLS.
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Private Label Registrar: TMC worked with a FDA compliant company to become a Private Label Registrar to manage and oversee the private labeling process, ensuring that all products met regulatory requirements and were correctly branded for the market. TMC consulted the Medline database which is the database of National Library of Medicine.
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cGMP Verifications: TMC prioritized cGMP (current Good Manufacturing Practices) verifications to ensure that all products maintained the highest levels of safety and quality during the COVID-19 pandemic. It is highly critical that the contract establishment facility must be audited and GAP analysis is done from Day 1.
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OTC Drug Label Development: TMC developed OTC drug labels that complied with FDA guidelines, ensuring clear and accurate product information for end-users.
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Brand Development and Marketing Support: TMC managed brand logo design, brand visibility design, product label design, product package design, website design, marketing flyer design, barcode registration, Daily Med registration, FDA registration, Google ad campaigns, document, photo, video productions.
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Compliance Strategy: The integration of cGMP verifications, extensive research, IT-driven data management, adherence to 21 CFR Part 11, Annexure 11, GAMP 5, 21 CFR Part 820, and thorough contract verifications formed the core of TMC's compliance strategy, ensuring the delivery of safe, effective, and compliant products.
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Extensive Research and Due Diligence: TMC invested significant time and resources into researching and verifying regulatory requirements, including FDA drug compliance, ensuring that all manufacturing processes and products adhered to the most stringent standards.
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Contract Verifications: Through meticulous contract verifications, TMC aligned all agreements with manufacturing partners to comply fully with FDA drug regulations, particularly cGMP (current Good Manufacturing Practices) requirements.