Testing Services

Lumena Pharmaceuticals operates state-of-the-art biological research and testing facilities which provide invaluable services to our strategic partners. Although our portfolio represents many years of knowledge and progress with a primary focus on the positive impact of human health. Each step forward has shown us how much progress there is still to be made.

Expertise

Our scientists, researchers and biochemists are experts in Analytical Chemistry, Microbiology and are fully trained in all areas of Regulatory Compliance. We have the ability to test for heavy metal contaminants, residual pesticides and microbial contaminants. We are able to provide GMP-compliant certificates of analysis for any raw material or finished nutraceutical products. We are also able to create custom testing panels for your specific needs, please contact us for more information or to understand how our testing services can help your company can achieve your product goals.

Quality Assurance

Product quality is ensured from beginning to end with raw materials being controlled and inspected, in-process and final product testing against written specifications, and final inspection based on published sampling plans before a product is released for sale. Internal Quality Audits are performed periodically by qualified staff and vendor audits are performed on an as needed basis. Effectiveness checks are made through review and monitoring of product complaints, non-conforming materials, and corrective and preventative action programs.

Transparency

In an industry where transparent cost modeling is essential, the Lumena world-class quality and lean manufacturing that are everyday expectations, are met with knowledge, skill and a drive to do our best work.

Analytical Chemistry

Raw Material Testing Quality Control & Raw Material Testing

Before manufacturing begins, all raw materials must be tested for purity, identity and quality. Depending on the type of product (tablets and capsules vs. biotech products), as many as 60 raw materials might be needed for product development. The extent of raw material testing is determined by the manufacturer. A conservative approach would be to perform complete analysis of each lot of raw materials received, which is a process Lumena employs.

Lumena offers comprehensive testing services per GMP and pharmacopiea (USP, EP, BP and JP) standards and to your specifications. Our analytical chemistry and microbiology teams can help you with the necessary testing for raw materials, APIs, finished products, packaging materials and medical devices.

Because of the many different techniques associated with raw material testing, please contact our testing facility or make an appointment for an in-house consultation to discuss the testing you might require.

Testing Services for Raw Materials

• Physicochemical Properties
• Identity and Purity
• Assays and chemical tests
• UV/Vis
• FTIR
• HPLC
• GC
• IC
• ICP-MS
• Identification of active ingredients and impurities
• Physico-chemical determinations
• pH
• Viscosity
• Particle size
• Osmolality and osmolarity
• Loss on drying
• Limit tests
• Heavy metals
• Residual solvents
• Volatile organic compounds (VOC)
• Organic volatile impurities (OVI)
• Water testing for pharmaceutical purposes and controlled process environments (e.g. TOC, conductivity)

Microbiology

Lumena Laboratories provides a wide range of services within our purpose-built premiere laboratory facility, supporting our customers on both a global and local level. Our areas of expertise are in the pharmaceutical and biological home health care industries.

Lumena Pharmaceuticals is a provider of microbiological testing and validation support, we are unique in having recently built a state-of-the-art laboratory specific to our use and have the space advantage to continue to grow with the needs of our customers. We are excited to provide a comprehensive offering including laboratory testing, technical support and regulatory guidance.

Customer focus

When you partner with Lumena Laboratories, you enjoy a close working relationship with direct access to our experts on your project or routine analysis.

Our talented and experienced team is available to assist with any questions that may come up during the testing process. We pride ourselves on being exceptionally open and flexible – when requirements change mid-project (and they often do), we will do our utmost to help you meet any new objectives that may arise. Equally, we always let our customers know of any developments that may affect their project or their timeline in any way.

We understand, appreciate and respect budgets, and in doing so, are especially committed to finding cost-effective solutions to meet your requirements and your production deadlines.

Lumena Laboratories offers the following services:

• Raw material analysis
• Stability studies
• Microbiological and pharmaceutical testing
• Cosmetic analysis
• Laboratory testing
• Validation services
• Disinfectant qualification services
• Steam Sterilization
• Manufacturing and packaging
• We also offer training and consulting services specifically designed to meet our Customers’ needs.

Regulatory Services and Compliance

Lumena Pharmaceuticals services can assist you in ensuring the quality and acquiescence of your nutraceutical product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, we can shepherd your products through design, labeling, promotion, production, and testing.

Our services include:

Regulatory Affairs

Regulatory affairs are Lumena’s backbone and we fully understand the complexities of the nutraceutical industry. Our expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post market support.

• Formulation and GRAS applications
• Marketing Applications
• Medical Writing
• eCTD Publishing & Submissions
• Strategic Consulting & Intelligence
• Project Management Support
• Clinical Development Support
• Clinical Research Organization (CRO) Sourcing
• Analytical Development Support
• Bioassay Design & Validation
• Immunoassay Support
• Statistical Analysis & Specification Setting
• Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and we are responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Lumena can help.

Assessments

• Current Good Manufacturing Practice (cGMP)
• Corrective & Preventive Action (CAPA), Investigations & Deviations
• Data Integrity
• Quality System Gap Assessment
• Audits
• Supplier Audits
• cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
• Preparation, Training & Inspection Readiness
• cGMP Fundamentals (Annual Training Required by Regulations)
• Quality System Regulation
• Risk Management
• Investigations, Deviations & CAPA & Root Cause Analysis
• Validation & Technology Transfer
• Purchasing Controls & Supplier Management
• Document Management & Change Control
• Audit Readiness
• Quality Culture & Management Responsibility
• Data Integrity & Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
• Quality Assurance

Lumena’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs with your long-term goals through a viable and realistic strategy. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

Quality Management System Implementation

• SOP Development
• Document Control Systems
• Change Control
• Laboratory Operations & Control
• Remediation Strategy & Response

Lumena is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation.

With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

Regulatory Action

• 483 Response & Remediation
• Warning Letter Response & Remediation
• Consent Decree Response & Remediation
• Oversight Services
• Consulting
• Comprehensive Audits
• Remediation Plan Development & Implementation
• Manufacturing Support
• Re-validation of Existing Equipment & Processes
• Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility