Our Services
Leader Compliance helps Pharma, Biotech, & Medical Device Industries businesses navigate the ever-changing regulatory landscape. We offer a range of services to ensure compliance with CQA, Audits, SOPS, QMS, GLP, GCP, GMP, 21 CFR 11/Annex 11/Data Integrity/AI, Risk Assessment, Inspections
and other relevant standards.
What We
Offer
Clinical Quality Assurance (CQA)
Leader Compliance provides comprehensive Clinical Quality Assurance (CQA) services to ensure the integrity and reliability of clinical research. Our experienced team assists clients in developing and implementing robust CQA programs, including SOP development and training, quality risk management, data integrity audits, and corrective and preventive action (CAPA) management.
We help clients meet regulatory requirements, minimize risk, and maintain the highest standards of data quality and patient safety throughout the clinical trial process.
Audits
Audits are the linchpin of quality and compliance within the biotech and pharmaceutical industries. These rigorous examinations, conducted both internally and by regulatory agencies, scrutinize every aspect of a company's operations. Internal audits proactively assess adherence to established quality management systems (QMS) and identify areas for improvement. External audits, often unannounced, are conducted by regulatory bodies like the FDA or EMA to ensure compliance with strict regulations governing everything from research practices to manufacturing processes. These audits delve into documentation, data integrity, and production facilities, leaving no stone unturned. By proactively preparing for audits and addressing any identified shortcomings, biotech, and pharmaceutical companies can demonstrate their commitment to quality and ensure the smooth development and delivery of safe and effective medications.
Our audit services include audits by former FDA personnel, for a more in-depth audit.
SOPs (Standard Operating Procedures)
Standard operating procedures (SOPs) are crucial in the biotech and pharmaceutical industries. These procedures provide a set of guidelines for employees to follow when performing tasks, ensuring consistency and quality in the products and services provided. SOPs cover a wide range of activities from manufacturing and testing to documentation and record-keeping. They are designed to comply with regulatory requirements and industry standards and are regularly reviewed and updated to reflect changes in technology and best practices. Adherence to SOPs is essential for maintaining safety, efficacy, and compliance in these highly regulated industries.
Correct creation and execution of SOPs increase productivity and reduce time spent on errors and duplication. For that, we use the principle of “One should aim not at being possible to understand, but at being impossible to misunderstand” (Quintillian, 35AD). Our SOPs are written to be impossible to misunderstand.
This coupled with Lean Documentation, provides an SOP landscape that is easy to follow and understand while streamlining the creation and maintenance of SOPs, reducing effort, costs, and errors.
QMS (Quality Management Systems)
Quality management systems are crucial in the biotech and pharmaceutical industries to ensure the safety and efficacy of products. These systems involve a set of procedures, policies, and software that are implemented to maintain consistent quality throughout the entire product lifecycle. They cover everything from research and development to manufacturing, distribution, and post-market surveillance. By adhering to these systems, companies can minimize the risk of product defects, recalls, and regulatory non-compliance, which can have serious consequences for both patients and the industry as a whole.
Our experience in QMS goes back to when QMS systems were a collection of document management, CAPA, and other systems and we have continued to implement QMS systems through the years, always using the latest appropriate technologies. In short, we have seen it all!
We are currently partnered with 3 separate QMS system providers that can be evaluated for your needs, or we can select, evaluate, implement, and maintain QMS systems specific to your company.
21 CFR 11/Annex 11/Data Integrity/CSV/CSA
In the biotech and pharmaceutical industries, compliance with regulations such as 21 CFR, data integrity, computer system validation (CSV), and the Controlled Substances Act (CSA) is crucial. These regulations ensure that products are safe, effective, and manufactured in a controlled environment. Data integrity is particularly important, as it ensures that the data used to support product approvals is accurate and reliable. Compliance with these regulations is essential for companies to maintain the trust of their customers and regulators, and failure to comply can result in significant financial and reputational damage.
We have extensive experience in this, including co-authoring the original 21 CFR 11 regulation with the FDA, prototyping “General Principles of Software Validation” with FDA, Co-Authoring “Data Integrity” Book with SQA, contributions to GaMP 5 methodologies, and providing national and international training. Our team has led or participated in the implementation of upwards of 100 projects, and uses Lean Methodologies to reduce errors, effort and rework, providing sleek ways to complete any implementations that you might have.
Vendor Management
Vendor management is a term that describes the processes organizations use to manage their suppliers, who are also known as vendors. Vendor management includes activities such as selecting vendors, negotiating contracts, controlling costs, reducing vendor-related risks, and ensuring service delivery.
The vendors used by a company will vary considerably depending on the nature of the organization and could include companies as diverse as CROs, CMOs, Laboratories, IT vendors, and medical writing compliance. Vendors can also range in size from sole traders to large organizations.
We have extensive experience in vendor selection, qualification, management, and maintenance of vendors, to meet regulatory requirements and keep vendors performing at their best. Our experience includes small vendor projects such as vendor acquisition for non-GLP studies, and managing multiple CROs on an international basis. We bring extensive vendor selection experience that provides for vendor strategy and ROI presentation to executive levels, or boards.
Risk Assessment, Mitigation and Management
Effective Risk Assessment, Mitigation, and Management are critical to safeguarding your business against potential threats. Our comprehensive Risk Management solutions help you identify vulnerabilities, assess their impact, and implement proactive strategies before they become costly compliance issues. With tailored approaches for your company, we ensure that you stay compliant, reduce uncertainties, and protect your assets. We have extensive experience in risk assessment, mitigation, and management, using ICH Q9, ISO 14971, ISO 27001, ISO 27005, and GaMP5. Ask us how we can help you protect and educate your company to stay compliant.
Inspection & Inspection Support
Leader Compliance provides expert guidance and support for regulatory inspections. Our team assists clients in preparing for and navigating inspections conducted by regulatory authorities such as the FDA, EMA, and other global health agencies.
We offer comprehensive inspection readiness assessments, mock inspections, and on-site support during inspections. Our goal is to minimize disruption, ensure a successful inspection outcome, and help clients maintain regulatory compliance.
Remediation
Leader Compliance assists clients in effectively addressing and resolving regulatory findings and deficiencies identified during inspections or internal audits. Our team provides expert guidance in developing and implementing comprehensive remediation plans, including root cause analysis, corrective and preventive action (CAPA) plans, and change management strategies.
We help clients demonstrate to regulatory authorities that they have taken appropriate steps to address identified issues and prevent future occurrences, ensuring ongoing compliance and minimizing regulatory risk.