Services
Good manufacturing practice (GMP) consultancy
Regulatory expectations from manufacturers are ever-growing and changing. Achieving a successful quality system fitting to your company internal strategy and processes can pose a difficult and time-consuming task, but having the right plan and resources makes it that more attainable.
- We provide the know-how in implementing or upgrading to GMP practices and achieving good manufacturing certifications and licences.
- GMP consultation according to EU GMP & US cGMP requirements
- Our services include
- Mock inspections and recommendations for improvements
- On-site cGMP consultations to implement regulatory compliant processes and systems
- Quality system design, documentation review
- Implementation of good laboratory practices and quality monitoring systems
- Support during inspection preparation
- Support regarding inspection findings and responses
- Compilation of applications for the required licenses including follow-up with the authorities
- Arrangement of Health Authority GMP inspections
- Business support for specific GMP projects
- GMP audits, including raw material supplier’s audits and mock audits
Project management
Current fast-paced competition in the pharmaceutical industry raises the expectations and requires efficiency. In such circumstances, efficient project management has become crucial.
- We provide the expertise and take care of your project from the very beginning to the end, so that it meets internal goals and expectations.
- Our services include
- Project design, developing project plan and timelines according to company strategies, expectations and budget
- GMP project management, implementing or upgrading to GMP practices
- Tech transfer projects
- User requirements specifications (URS)
- Qualification and validation projects (facilities, utilities, equipment, systems)
- Remediation projects
- Arranging EU pre-market requirements (EU quality control, batch release)
- Product launch management, including pricing and market access
Pharmaceutical development projects
Developing a concept or an idea to an actual product is a long, risky and complicated process, but worth all the effort in the end, once the goal is achieved.
- We ensure that your product reaches the goal as smooth and as quick as possible by providing strategy, consultancy and relevant arrangements.
- Our services include
- Due-diligence of R&D conducted processes and documentation
- Strategy development and consultancy on improvements
- Regulatory advice during early phases of pharmaceutical development projects
- Analysis of pre-submission requirements, regulations and guidelines
- Support during scale-up and remediation of any occurring issues
- Providing arrangements (R&D, QC, BE), ensuring compliance with regulatory requirements
- Providing arrangements and support in raw materials (including API) procurement
- Interaction with competent regulatory authorities during pharmaceutical development, as required
- Regulatory evaluation of project feasibility
Regulatory strategies, registration and product lifecycle management
Business expansion is usually faced with different challenges in the regulatory affairs field and requires continuous dedication and expertise.
- With our regulatory affairs competence, we make your registration process quick and smooth and take care of your product throughout its entire regulatory lifecycle.
- Our services include
- Preparation and submission of new marketing authorization (MA) application in EU (national, MRP, DCP, CP procedures)
- Management of regulatory procedures
- CMC services
- Interaction with regulatory authorities (NCAs)
- MA lifecycle management and maintenance (variations, renewals, PSUR)
- Compilation, management and submission of eCTD sequences
- Labelling, product information (SmPC, PIL etc.) and artwork management
- Local representative in Croatia for MRP, DCP, CP procedures
- Marketing authorization dossier due-diligence
- Medical device management, registration/notification, technical file/design dossier compilation
- Regulatory management of food supplements, analysis of pre-market requirements and compilation of documentation
- Regulatory management of cosmetic products, cosmetics product information files (PIF) and notifications (CPNP)
- Readability user testing reports and bridging reports
Pharmacovigilance
Nowadays stringent pharmacovigilance requirements are imposed, but only to improve patient care and safety, as well as reduce any associated risks, making the best use of your product.
- Our pharmacovigilance team manages and monitors all safety aspects of your product.
- Our services include
- PV system design and management, PV training
- EU QPPV; Local QPPV for Croatia
- Conducting on-site or remote PV audits
- Post-marketing case processing management, signal management
- EudraVigilance reporting
- Entry of medicinal products in the XEVMPD database
- Global and local literature screening
- Management of risk minimization measures (e.g., DHCP letters)
- PV in clinical trials, including DSUR (development safety update reports) preparation and case processing
- Assistance in preparation of safety data exchange agreements
- PV in Patient support (PSPs) programs Medical device vigilance
Medical writing & information management
Good quality documentation and effective communication ensure a smooth registration process, but also efficient and trouble-free product lifecycle management.
- Through detailed medical information analysis, we offer a wide range of medical writing services for regulatory submissions and also take care of any medical information enquiries during the product lifecycle.
- Our services include
- Periodic safety update report preparation, submission and management
- Addendum to Clinical Overview (ACO) preparation
- Risk management plan preparation and submission
- Writing of clinical and non-clinical overviews
- Writing of further clinical eCTD documentation (Modules 2, 4, 5)
- Writing and maintenance of Company Core Data Sheets (CCDS)
- Management of medical information (e.g., scientific questions, patient questions etc.)
- Management of product quality complaints
- Regulatory guidance on promotional activities and materials
