General expertise applicable to pharmaceutical, biotech and medical device industries:
- Process Excellence ( J&J Certified Black Belt)
- Technical writing of reports, regulatory filings, e.g. IND, NDA, BLA and PMA
- Technical and statistical assessment of data: practical, graphical and analytical
- Due diligence and compliance audits
- Develop training programs of practical knowledge for scientists and engineers
Medical device expertise
- Design Control process and procedure
- Technical Design Review – in depth technical design review with specific expertise with drug/device combination products.
- Expertise with process engineering of drug-device combination products, including drug coating of metallic surfaces such as stents or coating of polymers such as threads to achieve a benefit from localized drug delivery.
Biotech and pharmaceutical product development
- Pre-formulation through commercialization (QbD approach to right first time product development)
- Scale-up, process and equipment validation, technology transfer, sterilization, complex products, e.g. suspensions, controlled release, emulsions, microspheres, liposomes and drug/device combination products, specific expertise with sterile products including aseptic and terminally sterilized small and large molecules.
- Sterilization expertise with terminal and aseptic sterilization involving various methods of sterilization: steam, dry heat, gamma, e-beam and microwave including sterilization of peptides, proteins and polymers such as PLGA.
- Work to develop a sound business proposal for notable patents of academicians or private citizens for partnering with international pharmaceutical firms. Specialize in the business development for innovators located in Turkey and the developing markets.