- Benefits of Pharma Consulting
- Why Work With NSF?
Special Knowledge, Expert Advice
NSF stays at the leading edge of pharmaceutical consulting and keeps abreast of every major industry issue. Our consultants can advise you on a broad range of regulatory and technical matters, including:
- Implementation of cost-effective, compliant quality management systems
- Assistance with responses to regulatory inspection reports, warning letters, etc.
- Troubleshooting on a wide range of technical problems
- Advice on clinical study design and evaluation: Patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts, and publication development
- Review of validation plans and completed studies
- Regulatory compliance for computers and automated control systems
- Regulatory submissions: Fast track designation, IND, ANDA, NDA, and BLA filings as well as post-marketing submission support (PAS, CBE-30 and REMS reports)
- Meeting preparation: pre-IND, end-of-phase-2 (EOP2), and advisory committee
- Specialist microbiological advice
- Specialist advice on water systems and autoclaving
- Global regulatory filings
Benefits of Pharma Consulting
NSF’s team of consultants can offer services specific to your needs, including:
Compliance consulting: An in-depth audit of your operations, or those of a third party, to assess current levels of compliance with international GxP regulations and expectations.
Regulatory consulting: Target product profile, regulatory strategy, orphan drugs and unique and combination products (due diligence, regulatory pathways).
Mock regulatory inspections: We help you prepare for a regulatory inspection by carrying out mock regulatory audits in advance of the real thing. Consultants visit your facility and carry out an inspection in the style of the relevant regulatory body (FDA, MHRA, EMEA, etc.).
Due diligence audits: We assist pharmaceutical companies, investment banks and venture capital organizations in the process of due diligence for potential acquisitions, buy-ins, joint ventures and other investment projects.
Benchmarking audits: We assess your facilities, procedures and practices against current industry norms, based on our exposure to pharmaceutical companies, large and small, worldwide.
Why Work With NSF?
When you are very close to a problem it can become difficult to solve. At NSF, our pharma consulting team has extensive expertise in helping companies to systematically resolve problems associated with their products, processes, equipment and systems.
Many of our in-house experts formerly worked as regulatory inspectors and senior corporate compliance auditors with major multinational pharmaceutical companies. Rather than simply telling you where you fail to comply, the NSF team provides essential, pragmatic advice on how to achieve compliance in a cost-effective way. We work with you to ensure that remedial action plans are comprehensive, effectively implemented and, where appropriate, fully documented.
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