services For healthcare inudustry
Professional service
MAH Compliance & CMO management
MAH Compliance & CMO management
RP Service is represented by Aleksandra Podlaska, Responsible Person (RP) and RPi (import) with passionate interest in patient safety, eGDP and eGMP.
MAH Compliance & CMO management
MAH Compliance & CMO management
MAH Compliance & CMO management
Aleksandra offers compliance support to Marketing Authorisation Holders (MAH) and affiliates of MAH in the UK, ensuring their responsibilities are maintained; and helping with quality management of Contract Manufacturing Organisations (CMOs).
Compliance Monitoring
MAH Compliance & CMO management
Compliance Monitoring
Aleksandra have been deemed eligible by the MHRA to act as a
Compliance Monitor (CM) in MHRA’s pilot compliance monitor programme for GMP & GDP
remediation supervision activities.
scope of services
New UK WDA services
Corrections and Management of QMS
Post inspection Assistance
Help with premises design, assisting with quality documents, training staff and facilitating MHRA inspection.
Post inspection Assistance
Corrections and Management of QMS
Post inspection Assistance
Assisting with deficiencies identified during MHRA inspection, planning CAPAs and implementing remedial actions.
Corrections and Management of QMS
Corrections and Management of QMS
Regulatory support & Licence variations
Assisting with necessary changes to QMS (whether identified by MHRA or quality audits) and system maintenance.
Regulatory support & Licence variations
Regulatory support & Licence variations
Regulatory support & Licence variations
Assisting and managing your regulatory requirements, submitting necessary notifications to MHRA.
RPi services
Regulatory support & Licence variations
GMDP auditing service
Great Britain batch review and RPi market release.
GMDP auditing service
Regulatory support & Licence variations
GMDP auditing service
Quality GDP and GMP audits for quality compliance. Aleksandra is Cerfitied GMP Pharmaceutical Quality Systems (GMP PQS)
Auditor/ Lead Auditor
Contract RP, RPi & cm
Contract Responsible Person (RP), RPi (Responsible Person for import) and Compliance Monitor (CM)
Aleksandra offers Contract Responsible Person services, RP & Deputy support, RPi services, and QA support; as well as Compliance Monitor (CM) services for GMP & GDP remediation supervision activities.
Please get in touch to discuss your requirements and find the best fit for your business!
Member and Practitioner of Chartered Quality Institute
The International Register of Certificated Auditors
Member of PQG - The Pharmaceutical Quality Group
Chartered Member
The Chartered Institute of Logistics and Transport
Member of Chartered Institute of Internal Auditors
Member of Institute of Export and International Trade
Member of European GDP Association
Member of European QP Association
Member of UK GDP Association
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Member of FSB - Federation of Small Businesses
