Expert Pharmaceutical Quality System Design and Support
UK, EU & US Pharmaceutical Quality Assurance and Compliance
Our Services
Specialising in the effective design and support of Pharmaceutical Quality Systems
Pharmaceutical Quality System Design
Mapping of Quality and Compliance requirements to business processes whilst working with your team to attain operational excellence. Bringing expertise in the design of Pharmaceutical Quality Systems supporting Clinical Trials and a wide array of dosage forms.
Qualified Person and Technical Support
Harnessing experience across multiple dosage forms and across both branded and generic industries, Qualified Person support can provide valuable input into the Pharmaceutical Quality System whilst supporting the certification of medicinal products. Specific support can be provided in Technology Transfer, interim management of Quality teams and remediation programme management.
Consulting and Due Diligence
Assessment of technical capabilities, Quality System maturity and level of compliance to help your business make informed decisions during acquisition or integration activities.
Supply Chain Assurance and Compliance
Support of pharmaceutical supply chains through the provision of audits covering Active Pharmaceutical Ingredients, finished product manufacturers, testing laboratories and distribution activities.
Knowledgeable ‘Qualified Person’ Support
We reduce complexity while adding value to Pharmaceutical Quality Assurance and Compliance
Our Experience
We provide value adding support to pharmaceutical businesses across the globe
API audits (chemical, classical fermentation and biotechnology), clinical trial sites, excipients, packaging components, testing laboratories and distribution sites.
Due diligence support associated with acquisitions and integrations.
Technical direction for Generic companies managing technology transfer projects to countries including India and China.
Qualified Person mock inspection for Biologics Manufacturer (and ongoing QP support).
Design and implementation of Pharmaceutical Quality System based on ICH Q10 for US pharma company.
International Expertise
'Qualified Person' services for the UK, EU and US Pharmaceutical Industries
Interested in Working with Us?
We are committed to providing support and design solutions for pharmaceutical companies requiring effective and innovative Pharmaceutical Quality Assurance Systems. Contact us to find out how we can help you.
Companies House No. 02919580
Old Harlow
Essex CM17 0ET