Quality and compliance (QP/QA) Services

Comply Services has a team of Qualified Persons (EU Directive 2001/83/EC art 49 and accredited according to Belgian Royal Decree of December 14, 2006), Responsible Persons (GDP ) and QA professionals who provide quality and compliance services to pharmaceutical and biotech companies in Europe.

Our customers are API manufacturers, formulation sites, packing sites, quality control laboratories, product release sites,  warehouses for storage and handling, distribution sites and wholesalers for marketed products as well as investigational medicinal product supplying sites.

Comply Services assists Marketing Companies with their quality support role regarding customer complaints handling, handling of major quality issues and product recall.

We also offers in-house QP training and coaching by experienced professionals.

Offering QA/QP experience and expertise

Comply Services responds to the typical requirements for contracted QA/QP roles in the following ways:

Experience

Our staff has sound knowledge and broad experience gained over many years in both local and international companies. They have demonstrated capabilities in Quality Systems and Quality Assurance Management as Qualified Person and in Leadership roles.

We offer a “hands-on” approach based on operational and organizational skills that we developed in various environments such as manufacturing sites, laboratories, warehouses and distribution sites and up to post-marketing QA services at marketing companies.

Expertise

Our staff has expertise in cGMP and GDP implementation and pharmaceutical regulations on manufacturing and distribution .
We take account of routine quality assurance tasks as well as QA management and product release by a QP.

In addition to executing the strict QP tasks and duties,  Comply Services  can be consulted for specific areas:

• Setting up a stability testing program.
• Quality issue management process and procedures for non-urgent recall and for emergency recall.
• Independent QA and regulatory advice in supply chain projects or outsourcing of manufacturing or distribution. WeIt  offers expertise in developing  the associated quality assurance agreements and supporting documentation for update of  the manufacturing authorization.

Flexibility

Short term and long term QA/QP services that meet your required working regime.
Interim assistance for your QA/QP staff.
Training/coaching of your staff in order to establish an efficient and skilled QA organization.

Continuity

We ensure continuity of services through back-up within the Comply Services organization.
We provide for back-up of the nominated QP in case of holidays or absence.

Commitment

Our staff is motivated to add value to your organization with respect to the highest ethical standards and integrity.

Periodic follow-up

We schedule a periodic follow-up of service in order to maximize efficiency and share feedback.