Quality compliance services
Pharmaceutical Quality and Regulatory Services
Av-tech offers quality and compliance assistance to pharmaceutical and medical device companies that need assistance to develop and improve quality system or resolve compliance issues.
We have over thirty years of experience in the field of pharmaceuticals and medical devices specialized in manufacturing, quality and clinical compliance. It also collaborates with international experts able to provide normative and procedural support to companies interested in European and non-European markets.
We can provide a short or long term assistance, provide interim management as a team member to support, guide and ensure compliance. We have experience in guiding startups in the field of pharmaceutical and medical device companies in performing activities to achieve in the most practical way compliance approvals with the FDA, ICH, ISO13485, and other regulatory standards.
Services will be provided on a professional and confidential manner, by understanding your needs and taking a personal approach.
The activities that we are able to perform relate to the following items:
- Develop, implement and maintenance of GXP Systems. Issuing and maintaining of quality manual and quality procedures for compliance with FDA, ICH, ISO 9001, and ISO 13485, ISO 14155 regulations.
- Develop and prepare the documentation for the establishing of a GMP facility. BOD, Qualification Protocols, Validation Master Plan, Plant Master File.
- Prepare the documentation for Clean Rooms qualification, validations and operation.
- Internal and external audits (CROs, CMOs, Contract laboratories, Suppliers),
- Perform GAP analysis to assess your actual performance.
- Establish a deviation, MRB, CAPA, Training and Internal Audits systems.
- Preparation for Qualification and Validation activities
- Preparation of Working procedures, Plant Master File, Writing of BOD, DQ, IQ, OQ and PQ protocols.
- Vendor auditing and inspection
- Prepare procedures and documentation to conduct clinical trials.