Services
Customised documents, audits and GMP consulting
Need something written for your own site, or an expert to check your systems? Tell us what you need and we will send a scope and quote.
Customised documentation
Documents written for your site, products and equipment, not generic templates.
Customised documents
Site-specific documents prepared to your process, equipment and regulatory market.- SOPs and work instructions
- Risk assessments (FMEA, HACCP, QRM)
- Qualification protocols and reports (DQ, IQ, OQ, PQ)
- Site Master File
- Contamination Control Strategy (CCS)
- Other documents your inspection or customer asks for
Audits
Independent audits with a clear observation report and practical CAPA suggestions.
GMP, GLP and GDP audits
Internal or mock-inspection audits against Schedule M, WHO, EU GMP, US FDA and GDP expectations.Request a quoteVendor and supplier audits
On-site or document-based audits of raw material, packaging and service suppliers, with a qualification report.Request a quoteQuality systems
Build and strengthen the systems inspectors look at first.
QMS system development
Design or upgrade your quality management system: quality manual, procedures, formats and training.Request a quoteQuality risk management
ICH Q9(R1)-based risk management programme, risk registers and facilitated risk assessments.Request a quoteData integrity and GDP assessment
ALCOA+ gap assessment of paper and electronic records, audit-trail review and good documentation practice training.Request a quoteCAPA management
CAPA procedure, effectiveness checks and support for open or repeat CAPAs.Request a quoteDeviation, OOS and OOT management
Investigation procedures, root cause analysis support and investigation report writing.Request a quoteChange control management
Change control system, impact assessment formats and regulatory change classification.Request a quoteDigital QMS
Selecting and moving to an electronic QMS for documents, deviations, CAPA, change control and training.Request a quoteEngineering and technical
Technical support from equipment selection to validated methods.
Equipment selection and technical evaluation
User requirement specifications, vendor comparison and technical evaluation of quotes.Request a quoteCleanroom qualification
HVAC and cleanroom qualification: air changes, pressure differentials, particle counts, recovery and airflow visualisation.Request a quoteAnalytical method development
Method development, verification and validation planning as per ICH Q2(R2).Request a quoteRegulatory compliance
Close the gaps before the inspector finds them.
21 CFR compliance
Gap assessment and remediation for US FDA 21 CFR Part 210/211 and Part 11.Request a quoteRevised Schedule M compliance
Gap assessment and upgrade plan for the revised Schedule M requirements for Indian manufacturers.Request a quoteWHO-GMP, EU GMP and PIC/S readiness
Gap assessment and preparation for WHO-GMP certification, EU GMP and PIC/S-based inspections.Request a quoteEU GMP Annex 1 compliance
Annex 1 gap assessment for sterile and aseptic sites, including contamination control strategy and APS (media fill) review.Request a quoteInspection readiness and mock inspection
Mock regulatory inspection, front-room and back-room training, and a storyboard for critical topics.Request a quoteResponse to inspection observations
Help writing responses and CAPA plans for regulator, customer or certification-body observations, such as FDA 483s and audit reports.Request a quoteManufacturing licence and regulatory submissions
Document preparation for CDSCO and State licensing, site and product approvals, and CTD dossier sections.Request a quoteFSSAI, FSSC 22000 and ISO 22000 readiness
For food and nutraceutical sites: FSSAI licensing documents, HACCP plan and certification-audit preparation.Request a quoteBusiness and consultation
Run your plant better, not only more compliantly.
Productivity and cost optimisation
Review of yields, cycle times, rework and utilities to find practical cost savings.Request a quotePharma industry consultation
One-to-one expert consultation for any GMP, quality, microbiology or regulatory question.Request a quoteGMP and quality training
On-site or online training for operators, QC and QA teams: GMP, GDP, data integrity, aseptic behaviour, microbiology and investigations.Request a quoteNew facility and layout review
GMP review of new or expanding facilities: layout, people and material flow, zoning, HVAC concept and utility design.Request a quoteTechnology transfer support
Transfer protocols, gap analysis between sites, and support for exhibit and validation batches.Request a quoteContract manufacturer selection and due diligence
Finding and assessing loan-licence or contract manufacturers before you sign, or GMP due diligence before an acquisition.Request a quoteOutsourced QA and quality head support
Part-time QA or quality-head support for small units: document review, batch-record review and monthly quality reviews.Request a quoteOperational excellence (Lean and OEE)
Improve equipment effectiveness, reduce changeover and waiting time, and set up simple daily performance tracking.Request a quoteRequest a quote
How it works
- Send your requirement using the form.
- We discuss the scope with you on a call or WhatsApp.
- You receive a written scope, timeline and quote.
- Work starts after you approve. Confidential information is covered by a non-disclosure agreement on request.
Prefer to talk? Email shailendra.007chauhan@gmail.com or call +919756905530.
30 services available.