Peter Dellva

pharmaceutical fda fda compliance biotechnology process validation biotech accelerated approval drugs fda pre-approval inspection readiness biopharmaceutical combination drugs regulatory approval expedited approval drugs biomedical cell therapy big data compliance biologic project management antisense oligonucleotide oligonucleotide medical devices 21 cfr part 4 food and drug administration pharmacutical process development and quality by design pai inspection readiness quality assurance regulatory submissions transfer and scale-up qbd development reports critical process parameter eva bioanalytical services process validation biotechnology project management on-site third party contract manufacturing support