Consultants for Quality & Compliance services

Quality & Compliance

Quality & Compliance in Pharma Manufacturing

We offer Quality Assurance and Compliance related services that suits your organization

Aptio Group has an experienced team of engineers, pharmacists and consultants ready to provide pharmaceutical and life science companies achieve and stay in compliance. Our team of skilled consultants has in-depth knowledgde and remains up-to-date on the latest legislation while meeting the requirements set by regulatory authorities. They are trained to identify potential compliance issues so that your business are able to resolve them quickly.

We ensures that Commissioning, Qualification and Validation planning and execution in pharma and medical device projects runs smoothly.

Our pharma experts provides service bridging all stages

We work closely with our clients to ensure that all quality related activities are carried out viably and effectively and in compliance with GMP. Our team are ready to support you in the following areas:

- - Quality Assurance (QA) of manufacturing activities, incl. Change Controls, preparation, reviewing and handling SOPs, Qualifications & Validations, CAPA and deviations.
  - Quality Assurance (QA) in accordance with GMP regulations, quality agreements and Marketing Authorizations.
  - Quality Assurance (QA) of Facility & Equipment.
  - Quality Assurance (QA) of Qualification & Validation projects
  - QMS update and maintenance.
- - Analytical test results review and approval
  - Method validations and equipment qualifications.
  - Prepare and maintain specifications SOPs, batch release documentation, and other GMP documentation.
  - Internal/external audits and regulatory inspections.
  - Project Quality Management System preparation and implementation
  - Quality risk management
  - Audits and Gap Analyses
  - Internal/external audits and regulatory inspections.Inspection Readiness services.

Contact Aptio Group

Do you need assitance in any area of quality and compliance? We’ve got you! Whether it is short or long term, do not hesitate to get in contact with us. Our consultants provide high quality services tailored to pharmaceuntical industry.

Fill out the form and we will get back to you as soon as possible.

GDPR Agreement

Declaration of Consent in compliance with GDPR I hereby give my consent for the processing of my personal data in accordance with the terms and purposes described below: Purpose of Personal Data Processing: The processing of your personal data is necessary for our recruitment process and providing our services to customers. Types of Personal Data Processed: The personal data that will be processed includes: • Full name, home address, email address and telephone number. • Application and CV, relevant information about your previous work experience/employment, education, courses, language- and IT-skills. • Letter of recommendation. Aptio Group CV: Your Aptio Group CV includes: Full name, job title, work experience, education, courses, language skills. This information can be shared with relevant customers. Aptio Group will contact you before sharing your Aptio Group CV. Data Controller: The data controller for your personal data is Aptio Group, with contact information as follows: Pia Rask Merkelsen, mail: piarask.jorgensen@aptiogroup.com Consent is Voluntary: You understand that consent to the processing of your personal data is voluntary, and that you have the right to withdraw consent at any time by contacting the Data Controller. The Applicants Rights: Obligation to provide information: Aptio Group has an obligation to inform the applicant about which personal data is processed about him/her. Right of access: The applicant has the right to access which personal data Aptio Group processes, including the purpose, categories of information and possible disclosure, etc. Right to rectification: The applicant has the right to have incorrect information about him/her corrected. Right to deletion: The applicant has the right to delete or stop the processing of information that is no longer relevant or where the basis for the processing is no longer present. Right to object: The applicant has - for reasons relating to the individual's particular situation - the right to object at any time to illegal or unjustified processing of personal data. Right to complain to the Data Protection Authority. See contact information at www.datatilsynet.dk. Validity of Consent Declaration: This consent is valid in 12 months. I hereby confirm that I have read and understood the terms of processing of my personal data, and I consent to such processing.

Next Section: Manufacturing Science & Tech Transfer

Read more about our services within the area of Manufacturing Science & Tech Transfer

Quality & Compliance

Quality & Compliance in Pharma Manufacturing

We offer Quality Assurance and Compliance related services that suits your organization

Our pharma experts provides service bridging all stages

Contact Aptio Group

Next Section: Manufacturing Science & Tech Transfer

Aptio Group Denmark ApS

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