Mandava Associates has a proven and successful track record in Pharmaceutical, Biological and Biotechnology product development. Some of the services that are covered under this area but not limited to are:

	FDA Pharmaceuticals and Biologics
	Absorption, distribution, metabolism and excretion (ADME)
	Analytical chemistry
	Bioequivalence issues
	Biotechnology
	Certification of Suitability (COS) to European Pharmacopoeia
	Chemistry, manufacturing and controls (CMC)
	Clinical Monitoring
	Conduct of Phase I – IV clinical trials
	Data development and strategy
	Data management and QA
	Drug delivery systems
	Drug development strategies and assessments
	Drug Master Files for US, Canada and EU
	Drug establishment registrations and drug product listing
	Enforcement and compliance issues
	Environmental assessments and impact statements
	Fine chemicals and intermediates
	FDA Liaison
	Formulation Development
	GCP, GLP and GMP compliance and audits
	IND, IDA, NDA, ANDA, BLA and NADA preparation and submission
	ISO 9000 and ISO 14000 programs and compliance
	Non-clinical program assessment, development and strategies
	Over the counter (OTC) drugs
	Package labeling and insert preparation
	Pharmaceutical Active Ingredients (PAI) issues
	Pharmacodynamics and pharmacokinetics
	Post submission support
	Preparation for site audit
	Product design and development
	Protocol development
	Quality assurance and quality control
	Regulations interpretation
	Regulatory management and strategic planning
	Safety reporting
	Special meeting preparation and briefing packages
	Study report and summary preparations
	Toxicology, pathology, microbiology and safety assessments
	U.S. representation before FDA
	USP testing and specifications
	Validation of data