Services

Our services are designed to support the Pharmaceutical and Medical Devices Industries and their business partners in achieving and maintaining regulatory compliance as well as developing and maintaining a robust Quality Management System (QMS). We can support a variety of companies such as manufacturers of starting materials, API and finished products, packaging, analytical laboratories, importers/exporters, distributors and wholesalers.

We offer consultancy services, training and support covering GMP, GLP, GDP, QA, QC, Auditing, Licensing, ISO accreditation, Quality management Systems (QMS), Quality Risk Management, Supplier Management, Management Review and governance as well as other quality and regulatory compliance services. Please contact us to discuss your requirements.

Quality Assurance

Gap analysis, development, improvement and maintenance of fully compliant quality system and associated processes, documentation and records.
Document control – SOP creation.
CAPA management
Training
Complaints management
Management review
Internal/external audits (self-inspection)
Supplier management
Specific quality/regulatory related documentation such as Site Master Files and Quality Manuals.

Regulatory Affairs

We can help you to increase awareness and understanding of the regulatory framework and how to apply it within your company.

Understanding the regulatory framework and its application.
Licensing and accreditation – submission of applications (new or variations) for licences or relevant authorisations related to GMP, GDP, controlled drugs and other GxP activities and operations.
Strategic approach to the ever-changing regulatory environment and reducing risk.

Training

Vita Scientiis can help you develop and maintain a culture of quality and compliance within your organisation by raising awareness and understanding of quality and regulatory requirements (GxP) at all levels within your company.

Develop and maintain a robust and overarching training program according to your needs.
Increase quality, compliance and risk awareness at senior management level.
Responsible Person (RP) Training.
QMS processes training (i.e. CAPA Management, Complaints, QRM, etc.)
In-depth training on specific subjects and processes for your hands-on teams and colleagues.

Auditing

Keep your auditing plans up to date and fully compliant. We can support with regulatory GxP and ISO 9001/13485 audits and inspections, as well as ensuring a robust procedure for CAPA follow up and management.

Supplier auditing.
Internal auditing and self-inspection.
Audit readiness

Compliance Monitor (GDP) – MHRA Eligible

If your company finds itself in the unfortunate situation of being placed under the MHRA’s IAG supervision, we at Vita Scientiis can help you regain and maintain compliance with the support of our MHRA eligible Compliance Monitor.

With over 30 years working in the pharmaceutical industry and logistics of medicinal, medical devices and healthcare products at an international level (Americas, Europe, Middle East and Africa), you can be sure that our CM’s knowledge and experience is second to none.

We can help you with

Ensuring your compliance protocol is completed in a compliant and timely manner.
Regularly review and assess all remediation work associated with the protocol.
Maintain timely communication with the IAG as agreed in the protocol.