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aptuit consulting overview
accelerating availability of new drugs for patients with serious disease
pharmaceutical salts and obviousness
implementing a preclinical program for biotechnology derived proteins
investigational new drug applications; same information different formats (us/eu)
application of 'omics technologies and pathway biology in pharmaceutical development
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Strategic Planning
Manufacturing
PreClinical
Regulatory
Clinical
GxP Quality/Compliance
Patent Support
Counterfeit Analysis
Asset Evaluation
Our Experience
Staff have doctoral degrees (PhD, MD, DVM) advanced certifications and on average 20 years of experience in the pharmaceutical drug and device industry
Proven track records in interacting with global regulatory authorities
Regulatory experience in all areas with small molecules and biologics
Anti-infectives, Oncology, CNS
Cardiovascular, Pulmonary, Rheumatology, Inflammation
Oligonucleotides, Peptides, Gene and Cell Therapy
Recombinant Proteins
Natural products
Photodynamic therapy
Combination products (device and drugs)
Due diligence support to companies and the investor community
Milestone-driven project development plans
Expert witnessing in all aspects of product development