GxP and Medical Device Compliance Services

Operational Compliance Services

We provide our clients with GxP and GMP services including auditing, inspectionpreparation, Raw Data Handling, Inspection remediation and QA support

 

GMP Compliance, Regulatory Affairs, Validation Services and Training

Throughout each phase of the drug and device development and manufacturing lifecycles, companies are faced with significant compliance challenges. By creating an integrated solution, Consultys is your single source for the insights and services needed to maintain the highest level of value and patient safety. 

We support LifeScience companies by providing the solutions needed to achieve and maintain full regulatory compliance. Consultys offers validation, QA compliance, and technical services in addition to pharmacovigilance and medical information solutions for our pharmaceutical and biotechnology clients.

Backed by years of experience, our trained team understands the needs companies have in this highly regulated environment. Consultys experts custom tailor solutions for each of our clients based upon their needs to achieve their goals. 

Our Consultys team includes GMP consultants and experts who have previously held senior roles within the industry and are able to consult on GMP compliance and QA other related issues.

We provide interim resources, GMP consulting and training on regulatory GMP compliance, Quality Management, Qualification & Validation and continuous improvement of manufacturing- / supplier processes.

Prismond Pharma GxP Compliance Services

Tailored GxP compliance services

Consultys team includes GMP consultants and experts who have previously held senior roles within the industry and are able to consult on GMP compliance and QA other related issues.

We provide interim resources, GMP consulting and training on regulatory GMP compliance, product registration, qualification & validation and continuous improvement of manufacturing processes and facility design and construction.

 
Quality Management System - Pharma

Quality Management System

Consultys offers a range of services and products aimed at delivering QMS compliance for complimentary medicine manufacturers.

Supplier Audits - Pharma

Supplier Audits / Vendor Assurance

Consultys can conduct on-site supplier audits on your behalf to ensure that their manufacturing activities are being executed according to your specifications and the applicable regulations.

GMP Compliance Mock Audits - Pharma

GMP Compliance (Mock) Audits

If you have a regulatory audit coming up, make sure you are ready by having a pre-audit by one of our experienced experts.

Qualification / Validation  - Pharma

Qualification/Validation Services

Validation Experts / Engineers experienced in FDA, EU and SwissMedic GMPs Consultys executes validation projects on a project or turn-key basis.

 
Compliance strategy development

Compliance strategy development

GMP compliance can be tricky - which regulations, which interpretation, where to start? We can help you develop a GMP compliance roadmap.

21 CFR Part 11 Compliance - Pharma

21 CFR Part 11 / Annex 11 compliance

US FDA CFR Part 11 Compliance / EU Annex 11 Compliance US FDA CFR Part 11 compliance means complying with the regulatory requirements for Electronic Records and Electronic Signatures (ERES).


Track and Track / Labelling - Pharma

Track and Trace / Labelling

Consultys can support you in regulatory and compliance aspects of EU/US Track and Trace regulations including T&T system implementations and all QA related topics as well.

GLC Laboratory Systems

Laboratory Systems (GLP)

Consultys provide GLP compliant laboratory services that meet the requirements of regulatory authorities for pharmaceuticals and also other regulatory analytical requirements such as biocides and agrichemicals, helping clients to achieve their scientific and quality objectives.