Expert Consulting for Pharmaceuticals manufacturers

Pharmaceutical Consulting Services

Expert guidance on regulatory requirements and licensing for pharmaceutical companies, including biologics and small molecules.

Licensing support

• Documents preparation, collections and submission for pharmaceutical products manufacturing licenses acquisition.

• Documents preparation, collection and submission for Active Pharmaceutical Ingredient manufacturing application acquisition.

• Documents preparation, collections and submission for pharmaceuticals wholesale distribution license acquisition.

Regulatory guidance

• Trainings of employees on different QMS topics including: deviations, complaints, OOS/OOT/OOE, CAPA management, change control process, trainings, aseptic techniques, qualification, validation, preventive maintenance and calibration activities, environmental and critical system monitoring including data trending and evaluation, manufacturing techniques in biologics, injectable, tablets, capsules and their packaging including serialization.

Employees trainings

• Support in preparation of documents for compliant QMS according to EU and FDA.

• Support in upgrading the current QMS according to EU and FDA requirements.

• Execution of internal and external audits in Lithuanian and EU with report and CAPA implementation management.

• Support in remediation plan preparation, implementation and management after complaints, withdrawal or warning letters.

Other services

Supporting with ISO and other certification of the organisation

Certificates acquisition and management

Standards acquisition and management

• ISO 9001:2015 Quality management system

• ISO 22000:2018 Food safety management system

• ISO 22716:2007 Good Manufacturing Practice for cosmetics

• Kosher certification

• COSMOS certification

• HACCP certification

• Halal certification

• BRCGS certification

Contact Us

Get in touch for regulatory support and consulting services.