2001 Pennsylvania Avenue NW
Washington, DC 20006
The Right People. The Right Solution. The First Time.™
Experts in pharmaceutical, biologics and biotech quality systems, compliance, regulatory affairs, auditing, education and training.
NSF Health Sciences Pharma Biotech Consulting provides international regulatory consulting services and training including FDA and EU expertise to support the development, manufacturing and marketing of pharmaceuticals, biologics, biotech biologics and combination products. Our core expertise is the design and implementation of successful efforts to resolve, or avoid, challenges posed in the development of new, innovative products. We work with a network of subject matter experts, across all therapeutic areas, to provide our clients with appropriate expertise in any field. We work to balance compliance with regulatory requirements with our clients’ business needs.
NSF Health Sciences Pharma Biotech provides these services:
- Quality systems implementation, remediation, compliance and assessment
- Inspection readiness and mock audits (GMP, GCP, GLP, BIMO)
- Third-party auditing and supplier auditing including management of supplier audit program
- Assessments for gaps, due diligence, data integrity and cost of quality
- Regulatory strategy/clinical trial support and submissions (IND, NDA, BLA, OTC, ANDA, etc.)
- Corporate compliance program design, implementation and sustainment
- Training and education
NSF Health Sciences Pharma Biotech maintains a commitment to outstanding service and quality, and focuses on achieving the client’s business objectives through the use of sound science and expert experience. Our total product lifecycle approach allows us to provide our clients with the best solutions for their regulatory needs.