Martyn Becker Associates provides specialist services in all GxP areas, bringing regulatory expertise to the manufacture and supply of all dosage forms, from the bulk API stage to finished products, using regulatory knowledge and experience from both Europe and the USA.

Based in the UK with global reach, Martyn Becker Associates provides a regulatory perspective on all aspects of pharmaceutical operation including manufacture, packaging, storage, distribution and laboratory operations to European, US and other global standards.

• Inspection Readiness to Quality Risk Management
• System design to pre-approval inspection-type assessment
• Internal/contractor auditing to training
• Facility design/re-design to facility health assessment
• Any other GxP-related activity

then Martyn Becker Associates has the experience and regulatory background to be able to help your business in the arena of global regulatory compliance - and all with an experienced Inspector's eye.

If you are looking for specialist assistance with European and US regulatory experience, and the expertise to make a real difference to your compliance posture through the use of actual recent regulatory experience, Martyn Becker Associates must be your first choice. There is no greater added value to your business than to be compliant with the spirit of GxP, and MBA provides the services that will add value and robustness to your processes.

• Aseptic manufacture/sterile medicinal products/non-sterile dosage forms
  - all aspects of guidance, audit and advice - from the regulatory perspective of an ex-Inspector who is routinely involved with the update of regulatory guidance
• Biological operations
  - specialist regulatory knowledge and experience in bulk biologicals, vaccines and other biological operations from an ex-biologicals/blood service inspector
• EU and US FDA Compliance assessment/recommendations
  - for all dosage forms and API facilities, and for suppliers to the pharmaceutical industry

• Quality By Design and Operational Support
  - building strong systems for the future
• Regulatory guidance
  - detailed EU and FDA expertise from an ex-Inspector’s viewpoint
• Inspection readiness process
  - detailed and formalised structure to get your operation ready for EU, US and other inspections
• Facility design/re-design expertise
  - proven experience in design/re-design of aseptic, biological and non-sterile operations
• Pre-approval assessment and recommendation, both US FDA and EU
  - mock-regulatory-inspection from an ex-regulator experienced in global GMP requirements
• Internal/supplier audit
  - 19 years' experience of all types of audit, self-inspection and regulatory inspection
• GMP training/education
  - proven excellence in motivation and communication
• Specific troubleshooting
  - 35 years' experience to cover all types of pharmaceutical situation