Our Quality Assurance & Compliance consultants can support our clients to ensure all activities, processes and procedures are carried out to the highest quality and accuracy standards. We can support our clients with GMP, GDP and GCP compliance of the business. We have several years’ experience in conducting internal and external audits of existing contract manufacturers and suppliers and conduct vendor assessment/selection for all new manufacturers, suppliers and providers. We have supported various Regulatory Authority Inspections and experience in hosting FDA, MHRA, HPRA, TGA, ANVISA and other regulatory audits. We can support our clients with the Continuous Improvement of all Quality operations. Our expert staff will help you find practical solutions for regulatory compliance issues, develop and maintain quality systems, Promote Quality awareness in the business and provide bespoke training as required. Your company will benefit not only from our experience and expertise, but also from the personal attention we give to each project and our dedication to providing high quality, cost-effective services.

Qualified Person (QP) & Responsible Person (RP) Services

The role and impact of QP on your business is vital. At BCI our team of QP's are fully conversant with GMP requirements in the regulated markets and have considerable experience in auditing in the healthcare, medical device and pharmaceutical industry. We assist you to achieve compliance and avoid issues with regulatory agencies.

Qualified Person Declarations:

Simplifying the preparation and submission process, we offer assistance with Qualified Person (QP) declarations, crucial documents affirming the compliance of medicinal products with regulatory standards. Our expert team ensures accurate and timely declarations, facilitating seamless regulatory procedures.

QP Product Certification:

Our QP certification service validates medicinal products' compliance with regulatory standards through meticulous verification and endorsement by qualified persons. With our reliable certification, we expedite market access and bolster product credibility.

Temporary QP Solutions:

When immediate QP expertise is required, we offer short-term solutions to fulfil responsibilities. Our experienced professionals provide temporary support, ensuring regulatory compliance and operational continuity during transitional periods.

Access to Market / Importation Services under MIA Regulations UK / EU:

Simplifying the importation process for pharmaceutical products, our services under Importation Authorisation (MIA) regulations ensure compliance and seamless market entry:

1. Importing authorisation
2. Marketing authorisation
3. Labelling and packaging provisions
4. Control of each batch
5. Pharmacovigilance system

Pharmaceutical Manufacturing Audits / Regulatory Audit Support:

Our QP/RP audit service conducts a comprehensive review of your pharmaceutical manufacturing processes to ensure compliance with relevant regulations and guidelines. Led by our team of qualified persons (QP) and responsible persons (RP), these audits identify areas for improvement and uphold rigorous quality standards.

Our consultants who have years of professional experience as auditors and deep regulatory insight will conduct mock GMP audits and provide expert guidance and advice to show you where you are compliant and where you have areas which you need to improve. We are therefore able to ensure our advice and services are always current and relevant while being flexible to meet the dynamic needs of our clients.

Regulatory Inspection Remediation Support:

  We provide comprehensive support for remediation efforts post-regulatory inspections. Leveraging our experienced team, we address findings, implement corrective actions, and ensure regulatory compliance to mitigate risks and maintain operational continuity.

Preparation for HTA Inspections:

Assisting organizations in preparing for HTA inspections, our tailored services help navigate requirements, address potential issues, and demonstrate compliance with HTA standards.

HTA UK Provisions Designation Assistance:

Guiding individuals seeking designation under HTA UK provisions, our experts assist in meeting eligibility criteria, preparing documentation, and navigating the designation process for involvement in HTA activities.

EU GMP Certification Readiness:

 Preparing organizations for European Union Good Manufacturing Practice (EU GMP) certification, our service ensures alignment with requirements, facilitating successful certification audits.

Quality Management System Implementation:

 Supporting organizations in implementing tailored quality management systems (QMS), we develop, document, and implement frameworks to foster a culture of quality and compliance within the organization.

Gap analysis & Remediation Projects

At BCI our compliance consultants provide a systematic review and guidance on identifying the potential gaps between your company’s current operations/systems and the prevailing regulatory requirements governing the company operations. These gaps (weaknesses) cause uncertain risks for the organization. This gap assessment conducted by our experts aims to improve the current status of your organisation by ensuring all the validation and documentation are correct and regulatory compliance for future products are fully met.

SOP creation / improvement / simplification

At BCI, our team of validation experts assist you in writing effective SOPs to ensure GMP compliance and adherence to GDP. Drafting an SOP is crucial and most integral part of almost all systems and operations which impact the quality and safety of pharmaceutical and healthcare products in achieving its pre-determined specifications. We help you to write user friendly SOP documents detailing the essential routine and recurring work processes that are to be followed within an organization correctly, consistently and in conformance with the internal procedures that reflect the current work practice.

Product Quality Reviews (PQR) and Product Annual Review (PAR)

Our quality management experts help to develop an efficient and compliant PQR/PAR program as expected by industry standards and guidelines. Product annual review (PAR) term used by FDA in their guidelines and Product Quality Review (PAR) term used by EU in their guidelines is a program that is compiled annually to evaluate the consistency of the process, verify the quality of the products, and need for changes in specifications, manufacturing, and control procedures. We help you in drafting an efficient PQR/PAR report by analysing investigations/deviations/change controls conducted, and product complaints, recalls and returns received. This report will help you to identify areas of improvement and to align processes to consistently manufacture quality products. We shall help you to review the product batches by capturing product data and trending the data. OOS and batch failures are also considered which will help determine the need for revalidation and changes.