Mandava Associates has a proven track record in the regulatory arena and has handled many submissions for companies globally to the FDA, Canadian, and European drug authorities. Our regulatory support services are based on providing our clients with the most efficient and cost-effective manner. The services that are offered include regulatory planning, management with full support and compliance. Some of the services that are offered but not limited to are:
Drug establishment registrations and drug product listing
Enforcement and compliance
Fine chemicals and intermediates
FDA Liaison
Formulation Development
GCP, GLP and GMP compliance, audits, and inspections
IND, IDA, NDA, ANDA, BLA and NADA preparation and submission
ISO 9000 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
Pharmacology and pharmacokinetics
Post submission support
Regulations interpretation
Regulatory management and strategic planning
Report and summary preparations
Results assessments, interpretation and integration
Special meeting preparation and briefing packages
U.S. representation before FDA
USP testing and specifications
Validation of data
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