About Us
Our Mission
Founded in 2011 by Kamila A. Novak, MSc, KAN Consulting provides auditing, consulting, medical writing services, and training courses to biotechnology and pharmaceutical companies and CROs as well as institutions and individual researchers – investigators to ensure compliance in the complex regulated drug and device development landscape.
Our goal is to support your business objectives and, ultimately, help patients to benefit from new therapies as soon as possible.
Your Consultant
Kamila A. Novak holds a master’s degree in molecular genetics. She has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant.
Her business activities include compliance audits, medical writing, and training.
Kamila Novak is a certified Lead Auditor for ISO 9001, ISO 31000, ISO 15189, ISO 27001, ISO 13485 , Certified Auditor for ISO 14155, and cGMP – QMS auditor. She is a member of the Society of Quality Assurance (SQA), the Association for GXP Excellence (AGXPE), the Drug Information Association (DIA), the European Medical Writers’ Association (EMWA), the Continuing Professional Development (CPD) UK, and other professional societies.
In the DIA, Kamila Novak serves as a Chair of the Clinical Research Community, a Core Committee Member of the GCP & QA Community, and leads the Computer System Validation Working Group.
Clients' Benefits
Everyone could do with a bit of extra time and money and KAN Consulting can help save you both. Whether you are a biotechnology or pharmaceutical company, an institution representative, an investigator, or a CRO, you may find something in our offer you can benefit from.
Institutions and Investigators
Institutions engaged in research, whether conducting its own or industry-sponsored projects, are more successful with functional research offices and adequately trained personnel. It relieves investigators and their teams from the administrative burden allowing them to focus on the science and patient care. KAN Consulting supports institutions wishing to enhance their research potential with
- Compliance audits and mock inspections,
- Training of personnel, including but not limited to GCP, regulations, study management for investigational sites, contract negotiation, protocol development.
Sponsors and CROs
Our industry clients are particularly interested in
- Audits such as Quality Management System (QMS), process, and computerised system validation audits, study audits, vendor (re)qualification audits, and audits of procedural as well as study-specific records (SOPs, CSRs, CIRs / CERs) and systems (eTMF), safety management and PV audits.
- Specialised training courses and workshops on project management, risk management, negotiation skills, presentation skills and business development.