Expertise you can afford

Committed to your success

Risk & Science Based, Phase appropriate

Validations

Achieve Efficient Validations

Risk & Science Based, Phase appropriate

Validation efforts can seem to last forever, with endless paperwork and prohibitive demands on the internal resources of a company. Our experienced and expert consultants can streamline your validation efforts. Our risk and science based and phase appropriate approach results in timely completions and cost-effective solutions, while meeting compliance requirements.

Validations on time on budget

We support the full spectrum of validation programs, from developing validation master plans to CQV of FUSE (Facility, utility, systems and equipment) through process validation and validation of supporting systems (Cleaning, Sterilization, CSV). For companies that get the right type of support and expertise, validation schedules are met and business goals achieved.

Whether you need validation help for a greenfield site or expansion of an existing commercial facility or are transferring products to a new company site or to a CDMO, our experienced consultants can ensure that you have the right level of expertise for a successful outcome.

COMPLETE VALIDATIONS ON TIME ON BUDGET

  • Facility, Utility, Systems and Equipment (FUSE)

  • Computer System Validations (CSV)

  • Process Validations

  • Cleaning Validations

  • Sterilization Validations

PROTOCOLS, POLICIES AND
PROCEDURES


  • Phase appropriate Validation Policies and Procedures

  • Master Validation Plans

  • Protocols, Executions and summary reports

Our Popular Services


Technical Consulting Services

Business Consulting Services

DOE/ Scale-up

CAPAS

Tech Transfer

Risk Management

Validation

CGMP Audits

Patents, Investors

Patent, Investor Support

Fractional R&D, QA Leadership

Reach out to thomas cgmp consulting

Get the most talented and committed process expert to meet your business needs