Compliance at BakerHicks means working with our Life Sciences clients to ensure absolute pharmaceutical quality. Batches of medicines or drug products need to be safe, consistent and effective and their production involves much more than pure materials processing.
BRINGING INNOVATIVE AND SAFE MEDICINAL PRODUCTS TO PATIENTS ACROSS THE GLOBE.
From ensuring that quality is built into the facility design, to the specification and monitoring of equipment and the training of client teams, our compliance experts have a detailed knowledge of good manufacturing practice guidelines and the latest in industry regulation.
This end-to-end experience ensures that strong quality management systems and operating procedures are in place, continually assuring the design, monitoring and control of a client’s manufacturing processes and facilities.
Responsible (or Qualified) Persons
Specialising in medicinal products, active pharmaceutical ingredients, excipients and food items, our FvPs, Qualified Persons (QPs), Responsible Persons (RPs) and quality managers support a range of Swiss life sciences clients.
With project services typically ranging from the release of bulk products (API), GDP release (transportation), quality assurance and quality control functions, our size and skillset mean we can quickly flex to a wide of range of QP requirements.
Good Clinical Practices (GCP)
Good Distribution Practices (GDP)
Good Laboratory Practices (GLP)
Good Manufacturing Practices (GMP)
Audits & Inspections
EU GMP Annex 1 Consulting
Authority liaison & inspections
Complaints, quality defects and CAPA management
Product quality reviews (PQRs)
Returns and batch recalls
Supplier / customer qualification
Method development, optimisation & validation
Certificates of analysis
Onsite QC support
GMP conformity & complaints
Standard Operating Procedures (SOPs)
Product quality reviews
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