Many healthcare companies are choosing to outsource some of their regulatory affairs and quality assurance requirements to ensure compliance and to accelerate implementation in today’s fast changing and increasingly complex regulatory environment.

The Consultancy Division of PBC Biomed is known for providing sound advice to client companies and has a respected track record in helping pharmaceutical and medical device companies achieving and maintaining certification and licensing in Europe, Australia, US and Canada.

Our support enables companies to focus their expertise on what they do best whilst leaving their regulatory and quality commitments to consultants who can ensure cost effective implementation and ongoing management of compliant RA/QA and Vigilance systems.

PBC BioMed’s regulatory support includes:

• Defining the regulatory requirements and pathways for new devices and medicines.
• Preparing and updating of technical files
• Managing Clinical evaluation
• Undertaking PSUR for medical devices
• Undertaking PMS for medical devices
• Supporting scientific advice pathways for medicines
• Preparing for certification audits
• Acting as local point of contact for Notified bodies and Competent Authorities
• Maintaining mandatory technical files (CE)/Marketing Authorisation
• Managing regulatory affairs in new markets
• Responding to vigilance issues, Warning Letters and Notified Body audit findings
• Complaint handling, contract review and surveillance audits
• Reviewing corrective actions and recommendation for resolution
• Acting as Marketing Authorisation Holder in Europe
• Acting as Authorised Representative in Europe

PBC BioMed’s QMS support includes:

• Design control and documentation
• Risk management
• Design verification and validation
• Process validation
• Staff QMS training
• QMS and supplier audits

For companies wishing to outsource their Vigilance system PBC BioMed offers a very comprehensive pharmacovigilance and device vigilance service.

1. Vigilance System set up
2. EU Qualified Person for Pharmacovigilance (QPPV) including PSUR and Risk Management for medicines
3. System Master File
4. Training
5. Audits
6. Literature Review
7. Case Management
8. Signal Management
9. Documentation Management

Contact us today to find out how PBC BioMed can help you.