CMC consulting services for biotech, pharma, CDMOs and 503B facilities
QLogixCMC works in seven practice areas, on your premises or remotely depending on the scope of work and the deliverables, separately or as one program. Each starts from the processes, systems and records you already have, and keeps every GxP decision with your qualified people.
- 01
CMC and regulatory
CMC consulting is the chemistry, manufacturing and controls work behind a regulatory submission: the control strategy, the specifications, the stability program, the manufacturing process description and the documents in Module 3 of the Common Technical Document. QLogixCMC plans that work for small molecules, biologics, sterile injectables, mRNA, cell immunotherapies and gene therapies, writes and reviews the documents from IND and IMPD through NDA, BLA and MAA, and supports the site through agency questions, post-approval changes and technology transfers.
Read about CMC and regulatory - 02
Quality systems and QMS
Quality systems consulting is the design, repair and digitization of a pharmaceutical quality system so that it meets 21 CFR Parts 210/211, Part 820 and ICH Q10 and fits the way the site runs. QLogixCMC assesses the system you have, designs or remediates the processes and procedures, and, where you choose, moves them onto a validated electronic QMS.
Read about quality systems and QMS - 03
Validation and computer software assurance
Validation is the documented evidence that a system, a piece of equipment or a process does what it is intended to do, consistently. QLogixCMC plans and runs validation that is scaled to risk: computer software assurance for computerized systems, qualification of equipment and utilities, and process validation across its three stages, with the evidence written so an inspector can follow it.
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Investigations, CAPA and backlog remediation
An investigation is the written, evidence-based account of what went wrong, why, what it affected and what will stop it recurring. QLogixCMC investigates deviations, out-of-specification results and complaints with your team, concludes root causes the evidence supports, writes CAPAs that can be checked for effectiveness, and clears aged backlogs to the same standard.
Read about investigations, CAPA and backlog remediation - 05
Inspection readiness and compliance remediation
Inspection readiness is the state in which a site can show an inspector, on request and from its own records, that it operates in control; compliance remediation is the program that gets a site back to that state after an observation, a warning letter or its own audit. QLogixCMC runs mock inspections and audits that find what an inspector would, prepares the site and its people, writes responses to FDA Form 483 observations and warning letters, and plans and manages the remediation to closure.
Read about inspection readiness and compliance remediation - 06
GxP systems implementation and administration
GxP systems implementation is the service in which QLogixCMC engineers, on your premises or remotely as the scope requires, bring the quality, laboratory or manufacturing system you have chosen live and then run it for you: implementation, configuration to your SOPs, migration of the records you keep, risk-based validation, and ongoing system administration with the users, roles, releases, periodic reviews and support a validated system needs.
Read about gxP systems implementation and administration - 07
AI and digital quality
AI and digital quality consulting is the work of bringing AI into a regulated quality system without losing control of it: choosing the use cases by risk, setting the governance, connecting the data the AI needs, designing workflows in which AI drafts and people decide, and validating the result. QLogixCMC does that work on the systems a site already runs or on the platform it chooses.
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Talk it through with someone who has run a plant
Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone.
In the first meeting we cover
- What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working
- What we would assess first, and what we would leave alone
- Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start