• Highly educated in economics, quality systems and quality auditors
• Experience in the generic pharmaceutical industry for more than 20 years in various countries on the globe.
• Formerly held senior positions at multinational pharmaceutical companies in Europe, USA and Asia
• Several API strategic sourcing projects in India and China

• Initiation, monitoring and project management of several product transfers from/to European and Asian sites.
• Initiation and management of first EU GMP accreditation project with Bangladesh pharmaceutical company along with CMO contracts with EUbased generic companies
• Lecturers in the field of marketing and supply chain
• Global key-level contacts in the pharmaceutical industry

• Our multilingual administration and translation team supports our experts while they are away abroad on project assignments on behalf of our clients.
• The following languages are available: German, French, English, Hokkian, Mandarin, Cantonese and Malay.

• With accumulated glossary know-how, over more than 10 years, our translation services are well appreciated by multinational pharmaceutical companies for their medical registration documentation.

• Profound professional experience as pharmaceutical technical experts for analytical method development for steriles and non-steriles finished dosage forms
• 30 years of practical expertise in the pharmaceutical industry in senior management positions (Head of Quality Control, Head of Quality Assurance, Qualified Person etc.)

• 30 years of practical know-how in regulatory affairs including upgrading of API DMFs, full compilation support in NeeS format Dossiers, ASEAN CTD format dossier compilation, connected with EU regulatory authorities
• QM documentation support – QA/QC

• Profound professional experience as pharmaceutical technical experts for sterile and nonsterile finished dosage form production
• Profound professional experience as pharmaceutical technical experts for API production
• More than 25 years experience in the pharmaceutical industry in various senior positions such as Head of Manufacturing, Qualified Person etc.

• Hands-on GMP consulting support in all aspects of production, utilities, process validation and all qualification aspects (IQ/OQ/PQ).
• QM documentation support – production and utilities

• Experienced experts in Information Technology Service Management (ITSM), GAMP (IT-GxP) and ISEC (Information Systems Security) specialists
• Multiple ITIL certifications
• Excellent knowledge of Computer Systems validation (CSV) and covering many other IT related fields

• Previouisly held various managing positions at several multinational companies like Novartis, Sandoz, Pidas in Austria and Canada
• Key experts for IT Quality, IT Service Management and IT Security and all related matters including but not limited to training, documentation support and SOP development.

• Former EU Inspector and freelance hired inspection associates are also part of the KIPA team
• Within their sound professional experience gained at EU authorities, these experts are very important in our GMP consulting projects acting as our internal inspector prior to real authority inspections. By performing these mock inspections and follow ups, we are confident that all high level GMP inspections can be passed.

• Our experts have conducted numerous regulatory GMP inspections on national and international levels for both API and Finished Dosage form manufacturers.
• Our experts gained experience in Asia, The Americas, Asia and Europe.

KIPA has access to a plethora of interesting generic product lines manufactured according to cGMP guidelines in Europe, Asia and Latin America and can offer the in-licensing and full project management.

Included are:

• Contract negotiation
• Analytical method transfer monitoring to the EU batch releaser
• Supply chain set up according to GDP
• Ongoing support during supply period and trouble-shooting if necessary