Rescop

WORLDWIDE SERVICES

PHARMA 4.0

WORLDWIDE SERVICES

GXP COMPLIANCE

WORLDWIDE SERVICES

TURNKEY PROJECTS & ADVISORY

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GMP CERTIFICATION FOR MEDICAL CANNABIS

WORLDWIDE SERVICES

DO YOU NEED HELP WITH FDA REMEDIATION?

RESCOP ACADEMY - Your partner for knowledge!

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GXP Compliance Services & Solutions

01 Qualification & Validation

Our international team of qualified experts is available for all your needs related to qualification and validation. We are preferred supplier for GxP regulated customers by worldwide everywhere on the website. Our services range from hands-on support to the development or improvement of the qualification and validation approach. Methodologies include GAMP 5, ASTM E2500 and agile validation

02 Auditing & Assessments

Our certified auditors perform internal and external audits based on applicable international GxP standards. To prepare for governmental inspections, our auditors can perform a mock audit. We can perform assessments of existing quality management processes to determine their maturity and identify potential efficiency improvements.

03 Quality Management

Our GxP Consultants support in establishing the required quality management processes, including design of quality management policies, procedures and work instructions. Furthermore, we train personnel in the application of the quality management system. Our consultants assess existing quality management systems and support with efficiency and maturity improvements. We also supply interim personnel to support quality operations, including quality officers, CAPA investigators, quality engineers, etc.

04 FDA Remediation

Upcoming FDA inspection? Our GxP consultants support in preparing for inspections by performing assessments of existing processes and performing any required improvements. A CAPA Plan is designed to define and monitor the improvements actions. Our consultants can support during the actual inspection and help with the remediation of any observations.

2000

PROJECTS

120

EMPLOYEES

200

HAPPY CLIENTS

64

ACTIVE IN COUNTRIES

We provide high quality and cost effective services.

FDA Remediation - 10 years Experience

Data Integrity - 11 years Experience

GMP Certification - 10 years Experience

CSV - 12 years Experience

Our Clients

Our Industries

Pharma / Biotech

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Medical Devices

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GxP Laboratories

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Medical Cannabis

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Diagnostics

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Related Markets

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Blog & News

2020-02-18 | by M. Kerens Cloud Computing in a GxP Environment - 26-28 February 2020 | Berlin, Germany

We are proud to announce that we will be a part of ECA – Academy conference on 26-28 February 2020 as a speaker. Our Chief Technology......

2020-02-03 | by B. Albeers The Benefits of Paperless Validation

Validation is defined by the Food and Drug Administration (FDA) as “Establishing documented evidence that provides a high degree of assurance that a specific process......

2020-01-21 | by M.KERENS ISO 27001:2013 Certified

Rescop, a Dutch-based GxP company, providing GxP Consultancy and creator of the RC-QMS Software Suite for small and medium enterprises and large organizations from around...... ...

2020-02-04 | by D.van Milde The smart pharma (4.0) factory

Pharma 4.0, also called the smart factory is a framework for adapting digital strategies to the unique contexts of pharmaceutical manufacturing. This means more connectivity,......