TRACK RECORD

HIGHLIGHTS FROM 7 YEARS OF CROP PROTECTION BUSINESS

Project leader and regulatory specialist for feed-through application of an insecticide, resulting in i.e. an US-EPA approved bolus formulation for cattle.

Development of a microencapsulated fungicide for seed treatment

Particle engineering for insecticide and miticide formulations.

Development and registration of Bacillus Thuringiensis formulations, including development of microencapsulated BTi.

HIGHLIGHTS FROM 14 YEARS OF ACTIVITY AS A PHARMACEUTICAL / CMC PROJECT LEADER

Compilation of pharmaceutical development reports for IND submission, based on individual scientific reports covering many years of development history.

Writing several subsidy request reports (NL and EU funds) on projects covering basic research through advanced pharmaceutical development.

CMC project leader for the transfer of the secondary manufacturing of a major marketed product from a large US/UK based company to Solvay Pharmaceuticals.

A project to increase the bioavailability of a marketed product. Next to internal developments, about 15 specialized companies were assessed with respect to their potential to assist in offering a solution. The project is still ongoing.

Assessment of about 20 CROs with respect to their potential for outsourcing pharmaceutical development activities, covering the compete area from preclinical development through pilot batch manufacturing.

Several years of experience with outsourcing both development work and bulk manufacturing of clinical supplies to Indian companies.

ACTIVITIES IN CONSULTANT WORK

Advising on a difficult NCE formulation project where activities at the originator company in Europe and a partner company in Delhi, India, were conducted simultaneously, resulting in co-authorship of a patent by the European company.

Report writing for the drug product Part II of the NDA for an NCE (originating from a EU company), including compilation of old development reports and raw data, partly in cooperation with a US partner company.

Auditing a small company in Mumbai, India, for manufacturing a Phase I formulation for an EU company.

Advising a small pharmaceutical plant in Karachi, Pakistan, on upgrading their development and trouble shooting processes.

Project management for a chemical company, where re-engineering of a pellet coating process is arranged by applying pharmaceutical technology.

Writing a report on possible new reformulation technologies for a generic drug product, for an EU company.

Advising a small pharmaceutical plant in Islamabad, Pakistan, on upgrading of their technology and GMP procedures for obtaining EU approval for their vaccine aseptic filling process.

Advising a EU pharmaceutical company on new technologies for solubilizing badly soluble NCE�s (including two draft patent applications).

Writing some parts of the drug product Part II of the NDA for an NCE (EU company).

Advising a pesticide manufacturer and formulator company in Shandong province, China, on setting up a formulation development lab, and troubleshooting a chemical process.

Team member with a US consulting company on a production process robustness enhancement project at a major pharmaceutical company in Ireland.

Literature assessment for product development of a line extension, EU company.

Advising a small biopesticide company in Bangalore, India, on formulation development.

Assisting an EU company on transfer of their IT system for pharmaceutical R&D inventory management.

Advising a Dutch life science company on development aspects of an NCE.

Advising a herb tincture manufacturer in Moldova on GMP aspects of their production facilities.

Advising a large soft gelatine capsule manufacturer in Colombia on reporting and regulatory issues.

Advising a herbal product manufacturer in Senegal on GMP issues.

Writing the development report for submission of the registration dossier of a new combination product for an EU company.

Advising a herbal product company in Bolivia on manufacturing documentation issues.

Teaching a small food and cosmetic company in Gambia how to make creams.

Advising a veterinary drug manufacturer in Jordan on GMP issues.

Working with a soap manufacturing company in Mali on improved recipes.

Advising a small company in South Africa on liquid soap manufacturing.

Assisting a Dutch biotech company in setting up a framework of GMP procedures.

Advising a pharmaceutical plant in Nepal on GMP issues.

Teaching a community of women in Niger to make toilet soap.

Performing an assessment of the Bolivian pharmaceutical industry with respect to GMP standards, by visiting 18 individual companies and presenting an anonymized overall report to CIFABOL. This was done in 2013 and in 2016.

Advising a herbal product manufacturer in Bangkok on technical process issues.

Advising the Faculty of Pharmacy of an Indonesian university to obtain ISO 17025 accreditation in order to deliver qualified analytical services.

Lecturer in a course for GMP auditors in Uganda, mainly on risk assessment in GMP.

Auditing a pharmaceutical company in Palestine.

Teaching a small cosmetic company in Hanoi on chemistry of emulsions and
ISO 22716.

Advising a pharmaceutical company in Nepal on a.o. risk management and cleaning validation.

Giving technological advice to a small cosmetic manufacturing company in Dar es Salaam, Tanzania.

Writing SOP’s for a biotech company in Nijmegen

Writing documents on risk management in pharmaceutical development and documents on impurities in stability studies for a CRO company in Breda.


Advising a spray dried food product manufacturer in Colombia on new technology.

Assisting a cooperation in Morocco on manufacturing and use of essential oils

Assisting a swimming school in setting up ISO 9001-2015 certification