Welcome

Veronika Lothian is a Quality professional and a QP with over 20 years experience in pharmaceutical and medical device companies such as Merck & Co and Abbott.

She earned her pharmacy degree at Semmelweis Medical University in Budapest, Hungary and became a QP in the UK in 2002.

Services

Qualified Person

Veronika Lothian is a qualified QP per Article 49 of 2001/83/EC directive since 4th of July 2002.

She was listed on the Manufacturer’s Licence of MSD Cramlington and released solid dosage forms (tablets, capsules and rapid dissolving tablets manufactured by a contract manufacturer).

She has 10 years experience on the medical device field as well hence well suited to release combination products.

She understands the importance and the impact of the QP role on your business and it’s interrelationships with the regulators and the ultimate customer the patient.

Quality Assurance

Veronika has spent over 10 years in the Pharmaceutical QA arena and 10 years in the Medical Device QA arena including:

process and cleaning validation
equipment qualification (IQ/OQ/PQ) & software validation
change control including regulatory submission support
compliance
annual product reviews
statistical analysis
complaint management

compliance review and inspection readiness
internal auditing
third party management
deviations
investigations
CAPA
stability program
batch review
batch release