Validation, process support, and technical writing for pharmaceutical, OTC, and personal care manufacturers. We build documentation that is complete, traceable, and ready for review at any time, whether your records live on paper or in an electronic QMS.
Science- and risk-based programs for pharmaceutical, OTC, CDMO, and personal care manufacturers. Our team writes to your templates, executes alongside your staff, and delivers right-first-time documentation your QA group can approve.
End-to-end qualification of facilities, utilities, and process equipment using risk-based verification. We cover compounding and liquid lines, filling and packaging, fluid bed dryers, blow-fill-seal, and aseptic and non-aseptic processes.
Full cleaning lifecycle support, from development through validation. We start with a program gap analysis against guidance and industry practice, then move into detergent selection, CIP recipe and cycle development, and SOPs. Validation protocols and periodic review close out the program.
Process characterization and qualification across formulation, filling, and packaging. We identify critical process parameters and quality attributes, qualify the process, and set up ongoing verification.
Generation and distribution loop qualification, three-phase PQ, sampling plans, and alert and action levels. We also design sanitization programs and validate SIP and sterilization processes.
Analytical and microbiological method validation, plus qualification of lab instruments. We cover residue methods for cleaning programs and compendial micro methods built around your SOPs.
Gap assessments, validation, and SOPs for electronic records and e-signatures, including platforms like DocuSign, LIMS, and data-logging software.
Risk assessments with practical mitigations, developed with your QA and site leadership. We also handle gap analyses, SOP authoring, CAPA support, and Lean Six Sigma process improvement.
Mapping studies for temperature-controlled units such as chambers, refrigerators, freezers, and incubators, plus seasonal summer and winter studies for warehouses.
Your documents are what inspectors read first, and what operators rely on every shift. We write the controlled documents a regulated facility runs on, so they're clear on the floor, consistent across the site, and aligned with the regulations that apply to you.
New documents, rewrites of legacy procedures, or a full document system for a new site, delivered in your templates and ready for your change control.
Many manufacturers straddle more than one framework, like a personal care site adding OTC drug products or a CDMO serving both markets. We write documentation that satisfies the one you answer to today and holds up if that changes.
Facilities, equipment, production and process controls, laboratory controls, and records for drug manufacturing, including OTC products.
Equipment and water system qualification, lab controls, and protocol and report structure for sites making or preparing to make OTC drugs.
Requirements for trustworthy electronic records and signatures used in place of paper and wet ink.
E-signature gap assessments and SOPs, system validation, audit trail and access control review.
Internationally recognized good manufacturing practice guidelines for cosmetic production, control, storage, and shipment.
Cleaning and sanitization programs, equipment and utility controls, and documentation practices for cosmetics and personal care sites.
Design, qualification, and monitoring of purified water, including TOC and conductivity limits.
Water system PQ design, sampling plans, alert and action levels, and trend review.
Microbial enumeration, tests for specified organisms, and verification of compendial methods.
Method suitability protocols built around your lab's SOPs and risk-assessed organism list.
Quality risk management, analytical method validation, risk-based verification of systems, and computerized system validation.
Scaling qualification effort to risk, validating cleaning and lab methods, and right-sizing computer system validation.
Not sure which framework applies to your site? That question is often the right place to start, and it's part of every initial gap assessment.
A defined path from first conversation to approved report, so your team always knows what's next and who owns it.
Review of existing documents, systems, and vendor packages against the requirements that apply to your site.
Risk-based scope, schedule, and protocols formatted to your templates and routed for approval.
On-site or remote support executing tests, recording data to ALCOA+ standards, and managing deviations.
Summary reports, SOP updates, and a monitoring plan your team can maintain after the project closes.
A Form 483 isn't a fine. The expense is the scramble that follows: pulling people off their day jobs to investigate, rewrite, retrain, and prove it's fixed, on the FDA's timeline instead of yours.
Business days FDA expects for a written 483 response before it may escalate3
One quality leader's estimate for a moderately bad 483, from internal teams, consultants, and hundreds to thousands of remediation hours1
A former VP of Quality's estimate for a single bad 483 once the root cause was fixed across all sites1
Of a business unit's sales, a widely cited benchmark for Warning Letter remediation cost2
The most-cited drug GMP observation, 21 CFR 211.22(d), is simply quality unit procedures that aren't written or aren't followed. It was cited 184 times on Form 483s in FY20244. Missing written procedures for production and process control, 211.100(a), consistently ranks near the top as well5. These are documentation problems, and documentation is what we fix.
Most manufacturers don't lack capable people. They lack time, and validation work stalls behind daily production. A dedicated professional moves it forward.
less internal staff time spent writing and revising protocols and reports
faster from project kickoff to approved protocol, on average
typical QA approval for delivered protocols, instead of repeated rewrites
Figures reflect typical engagements compared with sites drafting validation documents internally. Results vary with scope and site readiness.
A purified water system qualification called for 1,882 TOC samples across a year of performance monitoring. At $80 per sample, outsourcing that testing would have cost more than the analyzer itself.
We built a capital purchase justification comparing both vendor quotes against outsourced testing, including validation effort and ongoing monitoring. The in-house analyzer reached break-even during Phase 2 of the PQ, before the qualification was even finished.
An equipment vendor supplied an 82-page water system IOQ scheduled for on-site execution. A pre-approval review found 8 must-resolve issues and 8 redlines, and the protocol went back to the vendor before anyone ran a test.
A multi-site manufacturer adopted DocuSign so reviewers could approve documents from any location. A Part 11 and ISO 22716 gap assessment and a site SOP defined exactly when electronic and hand signatures apply.
Our consultants come from inside regulated manufacturing: validation engineering at CDMOs, cleaning chemistry and sanitization, analytical laboratories, and staff management on multi-site consulting projects. Together we've qualified solid oral dose, liquid, ophthalmic and inhalation, and personal care operations.
That background shapes how we work. Every deliverable is built to enter your quality system as-is: formatted to your templates, traceable to your requirements, and clear enough for the operator executing it on the floor. On-site and remote teams scale to the size of your project, from a single protocol to a full site program.
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.