Harita – Engineering, Validation, Compliance Project Consultants

Our Services

Harita has been providing the highest level of professional skilled and client orientated services to pharmaceutical and biotech companies.

Sterilization and Depyrogenation

Our experts have extensive background in microbe and bacterial endotoxin removal methodologies from test tube to active drug product. Every member of our team is meticulously trained on validation techniques using equipment such as Kaye Thermal Validator, wireless and wired loggers, pressure and Temperature data loggers. Sterilization expert providing full support for the site Sterilization platform including annual re-validation, Sterilization Validation Maintenance (SVM), and sterilization support services.

Lyophilization

Limited to no experience in dehydration of your product? Our team can help deliver end to end product preservation via freeze drying, including equipment installation and troubleshooting.

Cleaning, Process, and Equipment Validation

Equipment, utility, instruments, and container cleaning in clean rooms. Process and equipment challenge and characterization studies. Installation, operational, performance, process, software qualifications are few of the many actives our experts excel in. Process and Validation support including Engineering, Commissioning and Validation per regulatory guidelines for various projects including large and small scale sterilizers/autoclaves, dry heat ovens, incubators, cold rooms, shipping validation, CCIT and Utilities validation.

Technical Engineering

Our expertise include, but not limited to, production system development, facility and equipment installation and characterization, supply chain management, quality and regulatory compliance, parameter development, root cause investigation, and troubleshooting services. Phase II/III/Commercial Cell Therapy program. Cell culture product development engineering support including new equipment purchasing and qualification. We have experts supporting Phase I/II biologics pilot plants.

Project Management

We specialize in critical system and process evaluation, lean and six sigma principals application, financial evaluation, and risk assessment. As well as, timely delivery of project with utmost quality. We have experience in managing remediation projects for Consent Decree.

Automation

We provide full automation support for Laboratory and Industrial scale automation. Our experts can help you deliver custom automation to deliver quality and consistency to your valued customers. Utilizing latest technology and computer intelligence, we can help bring state-of-the-art inspection systems, high speed assembly, pick and place packaging, and distributed control using DeltaV system.

Our Story

At Harita, we are passionate group of professionals, dedicated to provide expert technical services to the biopharm clients. At Harita, our staff pay great attention to details and do not sacrifice our service quality for the sake of growth.

Clients We Serve

We bring unique perspective and streamlining to your projects to deliver highest quality of service in unimaginable timelines. We value our client's wish more than anything. Our current and past clients include:

Sanofi

Johnson & Johnson

Merck

Lonza

Alexion

Tengion

Morphotek

Aclaris

Impax Labs

Our Staff

Our staff includes an exceptional team of qualified professionals who have significant amount of education, knowledge and practical experience in biotech industry. Harita has a qualified and trained team, that will be dedicated to support your project needs. We are known for our technical expertise, and quality of work, flexibility of time (24x7 support) and outstanding track record. .