Regulatory Compliances Services

Additional Details

If you do, look no further than Regulatory Compliance Services, we provide comprehensive compliance services on all issues concerning your retail operations in the Pharmaceutical, Biotechnology and Medical Device Industries & for others industries.

 Regulatory Compliance Services strives to help you improve your relationships with regulatory agencies and reduce your potential liabilities stemming from adverse enforcement actions.

 Pharmaceutical Industry:

Do you need help to get your quality management system (ISO 9001) up and running? 

Are you having difficulty maintaining regulatory compliance between your manufacturing processes and the methods specified in the approved file? 

Do you need to perform a due diligence exercise on a product that you are interested in in-licensing?

Have you had notice of an imminent authority inspection?

 Medical Devices:

Do you need help to get your quality management system (ISO 9001; ISO 13485) up and running?

Do you need any support to create a quality system document in relation to regulatory requirements e.g. vigilance, risk management?

 Have you had notice of an imminent authority inspection? Do you need help with supplier audits, internal audits and/or pre-inspection audits? Real Regulatory has an experienced ‘lead auditor’ on hand who can help with this.

 If the answer to any of the above questions is yes, then you need Real Regulatory’s services.

 Find a suitable partner:

Real Regulatory can support you as your partner throughout the lifecycle management of your products. We can advise you and bring best value to the product each step of the way.

Pharmaceutical Industry:

Assistance clients with planning, developing and implementing a quality management system (ISO 9001:2008)

Provide guidance on all aspects of a quality system including training, documentation control, change control, pharmacovigilance and complaints, corrective and preventive action plan

Due diligence technical reviews and consulting

Perform Regulatory/Quality GAP Analysis and offer strategic advice

Conducting Quality and Regulatory system audits on behalf of client companies to ensure compliance with required quality systems, regulations and registered files

Medical Devices:

Working with clients to plan, develop and implement an ISO 13485:2003 or ISO 9001:2008 quality management system (or parts thereof) including CMDCAS

Conducting audits on behalf of client companies (supplier audits / internal audits)

Conducting pre-inspection audits to assess readiness for quality management system certification/registration

Creating /updating specific quality management system / regulatory processes, as required (for example, risk management as per ISO 14971, vigilance and/or adverse event reporting, etc.)

Languages for auditing: English and Germa.