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TechnoBusiness-Solutions.com
Providing results through competence, wisdom and agility since 1980

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Evaluating complex issues
Developing creative methods to problems
Implementing quality solutions for a profit

Give us your problem and we will give you a solution

Mr. Costas B. Chantzis, founder of our company, has had an impressive and verifiable list of industrial accomplishments for 26+ years (1980 to date) in Regulatory Compliance projects.

Call us at 908.387.0447

about our FREE*, one day Workshop

on Regulatory Compliance at your company's location

Our regulatory compliance services include:

Quality Systems
	Strategic Compliance Advice
.........	.......	Injunction/Seizure/Consent Decree Issues FDA 483 Citations and Warning Letters FDA and Advisory Meetings FDA Dispute Resolution Processes FDA Regulations/Expectations and Development FDA Regulatory Submission Preparation/Review Promotional Labeling and Advertising Issues
Due Diligence Audits and Remediation Plans
	State of Control and Regulatory Compliance
		Regulatory Files Independent Third Parties FDA Pre-Approval Inspections FDA Mock Inspections
Continuous Compliance Performance Monitoring
	GMP Computer and Automated Systems
Process Analytical Technology (PAT) and Quality Risk Management
	Process Definition, Characterization and Optimization
		Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Parameter and Process Boundaries Critical Installation Requirements Critical Operational Requirements
	Risk Assessment, Control, Communication and Review
		Failure Mode Effects Analysis (FMEA) Failure Mode, Effects, and Criticality Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Points (HACCP) Hazard Operability Analysis (HAZOP) Preliminary Hazard Analysis (PHA) Risk Ranking and Filtering
Commissioning, Qualification/Validation
	Equipment Commissioning Validation Strategy and Program Development Validation Assessment Validation Master Planning Installation Qualification/Operational Qualification Facility/Utility Validation Software/Part 11/Computer Validation Analytical Method Validation Cleaning Validation Metrology/Calibration System Standard Operating Procedures Preventative Maintenance Systems Equipment Qualification Process Validation Change Control Development and Implementation
Training

* Except any incurred travel, lodging and conference room expenses.

Ask Us About Our FREE Analysis of Your Material and/or Manufacturing Process Problem

Expertise

Pharmaceutical Consultant, Regulatory Compliance Consultant, Pharmaceutical Quality Assurance Expert, Quality Control Consultant, Regulatory Compliance Consultant, Product Development Consultant, Due Diligence Audit, Investigation, Expert, Engineering, Consulting, Services, Validation Study Consultant, Specialist, Investigation, Expert, Engineering, Consulting, Services
Expertise in quality control, quality assurance and regulatory affairs, medical products businesses, chemistry, manufacturing and controls (CMC) section of drug master files, DMFs, analytical methods and process plans, protocols and reports, form FDA 483 and warning letter responses, corrective and preventive action plans, training, general cGMP, general validation, and test method validation, negotiations with regulatory agencies, customers, distributors and internal group, data analysis including specification development and rationalization, trend analysis, expiration and retest date justification, test method characterization and validation, site qualification processes, product design validation documentation, test method validation document evaluation, data traceability audits, manufacturing process validation master plans, new product development, planned discontinuance of out-dated products, NDA pre-approval inspections, corrective actions, responses and re-inspection, chemical manufacturing processes, good manufacturing practice (cGMP), total quality management and ISO 9001 registration processes, in vitro diagnostic reagent, instrument design control and quality control. Expertise in pharmaceutical quality assurance, quality control, project management, regulatory affairs, product development, management, 26 years experience in product development, process development, validation, large scale manufacturing facility validation and startup, process development, validation, production management, quality assurance, quality control of FDA licensed biotechnology, small molecule and device products, regulatory experience, GMP audit, regulatory compliance, quality system development, validation, document control, laboratory management, facility environmental monitoring, internal compliance and auditing, process validation, microbiologic and chemical testing of materials and finished product, product stability, plant EM, product test and release programs, stability programs, instrument validation, and cleaning validation programs, statistical process control based production planning, QC laboratory management, drugs, ointments, creams, tablets, aseptic processing, powders, dissolution rate, deformulation, remediation, significant investigations, variances, protocol deviations, preventative actions, corrective actions

Take Advantage of our Special and Limited Time, FREE Offer:

We will do our best to help you determine the root cause of your material and/or manufacturing process problem, FREE of Charge.