ConsultancySpecial Knowledge, Expert Advice
NSF stays at the leading edge of pharmaceutical consulting and keeps abreast of every major industry issue. Our pharmaceutical consultants can advise you on a broad range of regulatory and technical matters, including:
- Implementation of cost-effective, compliant quality management systems
- Reduction in deviations and implementation of effective CAPAs
- 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
- Help with understanding the root cause of deviations and what leads to human error
- Reviewing practices to lead to human error prevention
We can perform 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.
We don’t just tell you where you fail to comply, we provide essential, pragmatic advice on how to achieve regulatory compliance in a a cost-effective way. Additionally, we will work with you to ensure that remedial action plans are comprehensive, are effectively implemented and where appropriate, fully documented.
We partner with you to add value to your business!
At NSF, we can audit any type of activity against all major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and more. Rather than simply telling you where you fail to comply, we provide essential, pragmatic advice on how to achieve compliance in a cost-effective way. We also work with you to ensure that remedial action plans are comprehensive, effectively implemented and, where appropriate, fully documented.
NSF’s auditing team 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, EMA, etc)
- Due diligence audits: we assist pharmaceutical companies, investment banks and venture capital organisations 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
It is unreasonable to expect vendors to accommodate audits from all their customers at times to suit their customers. And even if they could, they cannot possibly respond positively to the diverse and sometimes contradictory requests made by all
those customers. Again, this is where the third party experts can help. The organisation, Rx-360, which is discussed elsewhere in this Journal, was created to provide pharmaceutical manufacturers with the technical resource to perform an in-depth audit of suppliers and then to provide a report which can be used by Rx-360’s
membership. This satisfies the need to have confidence in the quality standards of the supplier without subjecting the supplier to a deluge of supplier audits from different companies with very different levels of experience and competence.
NSF-DBA is proud to be an approved auditor for Rx-360.
In addition to providing auditing services, we also provide auditor training.
Given the regulatory pressure on the pharma industry, a high level of scrutiny is being placed on the training and development of auditors and self-inspectors. We responded by re-designing and re-introducing an existing course with a qualification for pharmaceutical group lead auditors. The course is certified by IRCA (The International Register of Certificated Auditors), the world’s largest certification body for auditors of quality management systems, and meets the requirements of the FDA’s Pharmaceutical Quality Management System.
Our auditor course has been specifically designed to provide attendees with education, training and development to meet today’s pharmaceutical pressures, including the auditor skills and toolbox of auditing techniques needed by the successful pharmaceutical lead auditor. With content and delivery of EudraLex Volume 4, Chapters 1 to 9, ICH Q10 as the combined QMS, this is the first truly certified GMP auditor training course available globally today.
Other auditor training course topics include:
- Pharmaceutical Microbiology (QP4)
- Formulation and Processing (QP3)
- Quality Management Systems (QP8)
If you are already familiar with the subject matter, but want to explore, consider these:
- Industry norms and best practices
- Designing audit plans
- Evaluating observations
- Personal Q&A and tutoring
Training to be an Auditor
Bringing Added Value With An IRCA Certified Training Course
Pressure on the pharmaceutical industry to audit has never been higher and continues to increase. Supply chain decisions and batch release decisions are being made based on audits and self-inspections. As a result, a high level of scrutiny is being placed on the training and development of auditors and self-inspectors.
Faced with industry and regulatory pressure, NSF-DBA was actively encouraged to successfully redesign an existing, popular course and reintroduce it with a new qualification for pharmaceutical group lead auditors. The course, certified by IRCA (www.irca.org), the world’s largest international certification body for auditors of quality management systems, meets the requirements of the new Pharmaceutical Quality Management System.
The course has been specifically designed to provide delegates with education, training and development to meet today’s pharmaceutical pressures, including the auditor skills and toolbox of auditing techniques needed by the successful pharmaceutical lead auditor. Given the course focus, content and delivery of EudraLex Volume 4 Chapters 1 to 9, ICH Q10 as the combined QMS, the team at NSF-DBA sees this as the first truly certified GMP auditor training course available globally today.
Effective Pharmaceutical Audits and Self-Inspection (An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course) , U.S.A. 03/Mar/2014 San Mateo Marriott San Francisco Airport, San Mateo, CA, USA More Info Effective Pharmaceutical Audits and Self-Inspections (An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course) , U.K. and Europe 17/Mar/2014 Renaissance Manchester City Centre Hotel, Manchester, UK More Info Effective Pharmaceutical Audits and Self-Inspections (An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course) , U.K. and Europe 19/May/2014 Manchester Marriott Victoria and Albert Hotel, Manchester, UK More Info Effective Pharmaceutical Audits and Self-Inspections (An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course) , U.K. and Europe 22/Sep/2014 York Marriott Hotel, York, UK More Info 03/Nov/2014 Park Hotel Amsterdam, Amsterdam, The Netherlands More Info Effective Pharmaceutical Audits and Self-Inspection (An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course) , U.S.A. 03/Nov/2014 Boston Marriott Cambridge, Cambridge, MA, USA More Info
Through our sister company, Becker & Associates Consulting Inc., we now provide enhanced services to pharmaceutical, bio pharmaceutical and medical device companies worldwide, including:
- Approval Strategy
- FDA Interaction
- Advisory Panels
- 510(k), PMA, NDA and other submissions
- Quality Systems
- Audit Preparedness
- Form 483’s, Warning Letters and Consent Decrees
- Pre-clinical and Clinical Study design
- CRO Management
- Best Practice
- Expert Opinion
- Due Diligence
- Litigation Support
Click here to visit the Becker & Associates website