Services

Our Services

aptio group focuses on helping companies with the execution, interpretation and advice of regulatory and / or industry-required processes. These processes can be found either in legal texts and / or in various standards. We work cross-functionally where we handle issues within a company’s all different processes. We have a long and solid experience in, among other things, Life Science and the Automotive industry.

Our consultants help and support each other in each assignment so that customers always have indirect access to more than one consultant’s skills and experience. We always take great responsibility to do our utmost to deliver more or as expected and if required, we have an entire organization that supports with the skills and guidance required.

Hiring a consultant from aptio group will mean more than just hiring a quality consultant. Our consultants always have an additional consultant as a designated back-up and sparring partner. In addition to this, it is part of the employment at aptio group to be partly responsible for all our deliveries and to support their colleagues. This means that our customers always have access to more expertise than an individual consultant can offer.

Strategy

We plan, adapt and create structures based on regulatory requirements from, for example, authorities and / or industry-specific requirements or practices. Examples are requirements from the FDA, EMA , UN Global Compact or standards such as ISO 9001, ISO 13485, ISO 17025, ISO 14001, ISO 27001 and IATF 16949. We create models, quality systems and overall structures. This may, for example, but not exclusively consist of;

External market analysis
Quality management strategies
Develop and create a plan for quality management
Develop and create a plan for regulatory management
Develop and create a plan for sustainable development
Develop and create a plan for business continuity management

Implementation

We support the implementation of quality and management systems, models and / or strategies. This may involve a review of the business, current situation analysis, training of personnel and management as well as a review of current working methods and how it can be improved in order to best implement new systems, models and / or strategies. This may, for example, but not exclusively consist of;

GAP analysis
Current situation analysis
Implementation of quality management system
Training for personnel and management
Development of templates and the document
Write Standard Operation Procedure (SOP)

Control

We can be helpful in projects and high work peaks, as well as in organizations with ongoing work tasks and control of operations in areas that affect quality and compliance with applicable requirements. This may, for example, but not exclusively consist of;

Validation and Qualification (IT, processes, clean rooms, equipment, instruments)
CE marking
Regulatory requirements management
Risk management
Change management
Supplier Quality Assurance
APQP and PPAP documentation
Capacity study and Constraint Management

Performance

We can perform audits, both internal and external. We evaluate, analyze, optimize, verify, audit and improve systems, models and strategies. This may, for example, but not exclusively consist of;

Internal audits (First-Party Audits)
Supplier audits (Second-Party Audits)
Pre-audit prior to authority visit
Evaluation and analysis of existing systems and routines
CAPA handling
Complaint handling
Etc.

Training

We provide training in several areas that concern how to comply with and relate to current regulations and practices, primarily in the pharmaceutical, medical device, automotive and food industries. We can also customize training and seminars to our customers’ purposes and needs. The training may, for example, but not exclusively consist of examples below. We offer to customize training according to customers’ needs within Quality & Compliance in a wide perspective.

Good Laboratory Practice GLP
Validation, Principles and understanding
ISO13485; Current requirements and how to apply these to your business
HACCP; Basic education
AIAG-VDA FMEA
APQP/PPAP
IATF 16949, Current requirements how to apply these to your business
Internal audit training according to ISO 19011 guidelines

Recruitment Support

With good industry knowledge, we have the competence to support our customers when they are recruiting for vacant positions. We understand our customers’ challenges in both large and small organizations and what is required for the candidate in the position. Our work in a recruitment process is summarized as follows: