Your Partner in Pharma Compliance®
Delivering Sustainable Compliance Solutions®
We collaborate with pharma and biotech manufacturers, tailoring risk-based compliance solutions that address our clients’ unique challenges and mitigate risks effectively. CompliFirst specializes in assessing our clients’ GMP operations and processes to ensure that compliance becomes an intrinsic part of your firm’s quality systems. Our comprehensive suite of consulting services encompasses Quality Auditing, Quality Risk Management (QRM), Quality Assurance (QA), Microbiology, Quality Control (QC), and an array of other services crafted to meet our clients’ objectives.
Why Partner with CompliFirst
Our Values
Integrity
We consider integrity as a vital element in fulfilling our mission to ensure the safety and efficacy of life-enhancing products for patients. At CompliFirst, integrity is intricately woven into the core of our company’s brand.
Compliance
Our services are grounded on compliance as their foundation. Collaborating closely with your in-house team, we facilitate the integration of compliance-ready processes, ensuring a robust alignment with global regulatory requirements, compendial standards, and industry benchmarks.
On-Time Deliverables
Timely deliverables are among our foremost commitments to our clients. CompliFirst commits fully to each client’s project, striving to achieve on-time deliverables that meet or exceed our clients’ expectations.
Patient Safety
Ensuring patient safety holds paramount significance within our company values. We firmly advocate for the consistent, safe access of life-enhancing products to patients who critically depend on them for an improved quality of life.
Our Philosophy
At CompliFirst, we adhere to a “compliance-first” philosophy with an unwavering commitment. Our compliance services extend beyond merely identifying compliance gaps. We engage actively with your team to address Quality concerns, prioritizing compliance. We consider ourselves an extension of your internal auditing department, constructing a compliance framework that transforms your company’s quality systems and GMP processes into an inspection-ready state. Partnering with CompliFirst enables your organization to prioritize optimizing operations, while we ensure compliance.
Our Approach
1.
Client Consultation
Our services begin with a client consultation to evaluate our clients’ goals and objectives. Through a comprehensive consultation process, we gather vital information to formulate a remediation plan aimed at resolving your firm’s compliance issues and achieving your objectives.
2.
Compliance Assessment
Following the client consultation, we proceed with a compliance assessment to evaluate your firm’s current procedures and processes against prevailing regulatory standards. This assessment aids in determining your organization’s compliance status based on the requested services.
3.
Identify Compliance Gaps
After conducting the compliance assessment, we share our findings with your firm, revealing any compliance gaps present within your organization’s quality systems and GMP processes. The process of identifying compliance gaps enables us to spotlight the specific areas within your organization that necessitate remediation.
4.
Recommend Solutions
Using the identified compliance gaps as a basis, we proceed to propose sustainable solutions to resolve your firm’s compliance gaps. Our recommendations are closely aligned with industry standards and global regulatory requirements, ensuring the highest levels of compliance are attained for our clients.
5.
Remediate Compliance Gaps
We collaborate closely with your in-house team to resolve compliance gaps within your quality systems and GMP processes, reducing regulatory risk to your organization. CompliFirst offers hands-on expertise to support the implementation of the recommended compliance solutions for your organization.