BIOTECHNOLOGY

Our expertise and experience in the regulation of biotechnology and biological products includes the following areas:

• Regulatory Submissions

We have written the quality overall summary sections of the regulatory submissions for European and US licence applications for a number of innovative biotech products.

• GMP Compliance

Our consultants have long experience of writing the standard operating procedures and other documentation that is necessary to achieve European and US GMP compliance. We also offer GMP compliance auditing services including mock PAIs and pre-selection audits of contract manufacturing organisations.

• Validation Master Planning

Our approach to validation is based on a risk management approach and has been applied to the validation of processes, the qualification of facilities and equipment, computer systems validation and the validation of analytical methods. We can adapt this approach to your needs in Validation Master Plans and protocol documents.

• Interim Management

Our consultants have served interim management roles for biotechnology companies in the areas of quality assurance, quality control and validation management.

• Training

We can provide on-site training on any of the areas noted above. Please contact us to discuss your training needs.