Leander Biosciences Consulting

GxP Audits

Perform GMP, GTP and GDP audits as part of vendor qualification and surveillance audits.

Inspection Readiness

Support companies at the critical stage of preparing for regulatory inspections.

Program Development

Assist with the development of robust Quality Systems and various programs.

About Us

Leander Biosciences Consulting LLC is a global consulting firm offering a range of Quality and Compliance consulting services in the biotech and pharmaceutical industry. The company was founded by President Paul Leander who has 27 years of diverse industry experience in gene therapy, biologics and small molecule Quality and Compliance.

Our Mission

Collaborate with and advise biotech and pharmaceutical companies to ensure compliance with global health authority regulations.

Our Priority

Patient safety must be the most critical aspect of healthcare and will always be our #1 priority.

Services

Leander Biosciences Consulting provides Quality and Compliance consulting services to clients who are working diligently to produce life-saving drugs and medical treatments for patients in need.

Inspection Readiness

To achieve a state of inspection readiness, organizations must ensure that they have well established and robust systems including Quality, Production, Facilities and Equipment, Laboratory Controls, Materials, and Packaging and Labeling.

GMP Audits

Good Manufacturing Practice (GMP) audits must be routinely performed to ensure pharmaceutical companies have robust controls and systems including Quality, Production, Facilities and Equipment, Laboratory Controls, Materials, and Packaging and Labeling. GMP audits ensure the Safety, Identity, Strength, Purity and Quality of the product. These audits can also help identify deficiencies prior to a regulatory inspection which could result in repercussions such as an FDA Form 483 or Warning Letter. GMP audits are also conducted at Contract Development and Manufacturing Organizations (CDMOs) as regulatory agencies expect companies using CDMOs to ensure that outsourced operations adhere to GMP requirements.

GDP Audits

Good Distribution Practice (GDP) regulations describe the minimum standards that a distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the Supply Chain. GDP regulations are required by regulators in most regions of the world. However, the US FDA is different from all other agencies as there are no separate GDP regulations in place. FDA covers violations of storage and distribution under Good Manufacturing Practice (GMP) violations.

GTP Audits

Good Tissue Practice (GTP), along with Good Manufacturing Practice (GMP), are core FDA requirements for manufacturing products regulated as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and cellular therapies. These regulations are designed to assure high quality cellular and tissue products while maintaining control of potential infections, contaminations and other risk factors with such products. GTP and GMP also define the core elements of operational control and documentation required for manufacturers of such products. Deficiencies in GTP and GMP compliance can lead to FDA Warning Letters, sanctions and other punitive actions on the manufacturers of such products.

Program Development

Support companies with the development of robust Quality Systems and various programs.

Impressive Statistics

Years of experience working in Quality and Compliance.

GxP audits conducted globally.

Past and current global clients.

I worked with Paul in the Global GXP team at Biogen Idec, in Cambridge, MA, USA. Paul is knowledgeable in quality management and regulatory compliance, as it applies to GMP, and was building his competency in GCP. Paul is a self-starter, who is highly motivated and organized. Paul is a team player and demonstrated his leadership skills with his ability to inspire and motivate his peers. He is proactive and would often present ideas and solutions to senior management, to address challenges which faced the team. I came to appreciate Paul’s dedication, and willingness to learn and advance his skills. I am happy to recommend Paul and would work with him again.