Pharmaceutical Development Services and Registration of Innovative, Generic and OTC Medicines
Our Pharmaceutical Services
We are proud of providing a wide range of high-quality services in the following areas
New Products Development
Innovation, design and/or development of new products is a fundamental activity in order to cope with the dynamic pharma market.
PI Services has a multidisciplinary team that will accompany you throughout the whole product development process and manufacturing process. In this way, we will help you obtaining a suitable product, from the point of view of its stability, application and industrial manufacturing characteristics.
- Selection and qualification of suppliers (API, CDMO, CRO).
Search for funding and partnership. - Definition of the best regulatory strategy for the new product to access the market.
- Support in the formulation and development of analytical methods.
- R&D Strategy, technical feasibility analysis and risk assessment of the project.
- Conducting manufacturing and suppliers audits and DMF evaluation.
- Definition of project strategy and management of the activities and timelines, focusing on customers specific needs to deliver the best quality product on time.
- Galenic and analytical development advice and support during developmental phase including revision of technical protocols and reports.
Regulatory Affairs
PI services offers great expertise setting the best regulatory strategy to meet customer’s needs in different markets. Establishing the regulatory strategy is a key point of the project as it contributes from the outset to reduce the time to market, as well as feasibility assessment, timelines and costs.
In this area, PI Services can carry out the following regulatory services:
- Advice on the regulatory strategy of the product.
- Assistance to request Scientific Advice from all Health Authorities.
- Audit of Dossiers and GAP analysis.
- Preparation of the dossier in eCTD format and submission of registration dossiers at global level. Including Pre-clinical and Clinical sections, Investigational Medicinal Product Dossiers (IMPDs) dossiers, and DL response.
- Complete Regulatory Dossier Management and uploading in eCTD Software (Latok).
- Collaboration for licencing in and out.
- Life-cycle management of the medicinal product. Maintenance of a medicinal product including variations, renewals and notifications.
- Elaboration of Readability test.
- Preparation of documentation for the application for registration of the company as a Marketing Authorization Holder (MAH), including the following items: quality and pharmacovigilance documentation and support for implementing GDP certification.
CMC: Manufacturing and technology transfer
The transfer of technology and scientific knowledge are key steps to ensure the industrial implementation, an efficient supply chain and commercial production. Advice and support for the scale-up and implementation of manufacturing process and analytical methods in the host company.
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Writing and review of Active Ingredient Permitted Daily Exposure (PDE) Report.
- Nitrosamines Risk assesment Report.
- Risk assessment for preventing cross-contamination.
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CMO network optimization
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Supply chain analysis and simplification
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Inventory management
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Production planning evaluation
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Trouble shooting of mature products to improve robustness and cost efficiency
- QA assistance during manufacturing process
- Lifecycle management: Project management for the addiction of new API source, new manufacturing site, change of excipients/equipment, change of equipment, improvement of manufacturing process, etc.
Risk assessment and QA & Compliance
Quality risk management is a systematic process of assessing, controlling, communicating and reviewing the risks that affect the quality of a medicine. PI Services identifies risks throughout the entire product life cycle in order to increase the level of quality without lowering regulatory requirements.
- Elemental Impurities Risk Asessment (ICH Q3D).
- Support in the execution and evaluation of GXP audits and follow up of defficiencies and CAPA plan. Support in evaluation of effectiveness.
- Preparation of controlled standard operating procedures, working instructions and/or forms.
- Advice and technical support to implement Good Distribution Practices (GPD), supporting of all marketing authorisation holder (MAH) requirements until obtaining the Authorization and GDP Certificate.
Pharmacovigilance
Complete package of Pharmacovigilance (PhV) services is provided as we count on a global team of PhV experts including experienced PhV physicians and medical writing group. We will ensure that your company obtains high quality sevices and fulfils the regulatory requirements and industry standards.
Helping our customers meet demanding requirements, along with managing the risk-benefit profile of their products, we try to maximize product marketing potential, while ensuring patient safety. From outsourcing of individual activities to setting up and managing an effective and efficient global pharmacovigilance system, we provide tailor-made solutions for specific requirements.
- Risk Management Plan (RMP) elaboration
- Global and Local Literature searches (frequency to be defined with customers), reconcilation of cases and signal detection.
- Management of ICSR and L2A cases (EudraVigilance).
- Maintenance of Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
- Pharmacovigilance training.
- Audits (internal and third parties including vendors and/or partners).
- Support in case of inspection by the Competent Authority.
- Management of urgent safety communications with Competent Authorities; Monitoring of PhV perfromance, management of deviations and CAPAs
- Global and Local Literature searches (frequency to be defined with customers), reconcilation of cases and signal detection.
- Management of ICSR and L2A cases (EudraVigilance).
- Maintenance of Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
- Pharmacovigilance training.
- Audits (internal and third parties including vendors and/or partners).
- Support in case of inspection by the Competent Authority.
- Management of urgent safety communications with Competent Authorities; Monitoring of PhV perfromance, management of deviations and CAPAs
Clinical Studies
PI Services will support you in clinical data requirements as well as bioequivalence guideline. Our medical writers are experienced in managing updates to clinical evaluation and performance evaluation plans and reports to ensure compliance. In a case additional clinical data is required, we help you determine the appropriate clinical strategy, and we offer support with the design and set-up of the clinical trial, including obtaining all of the necessary approvals.
- Scientific advice.
- Elaboration and submission of Scientific Advisories to the Health Authorities.
- Selection and qualification of CROs, Research Centres and Phase I units.
- Start-up and monitoring of Clinical Studies (Phases I-IV).
- Preparation of Investigational Medicinal Product Dossiers (IMPDs).
- Support on Bioequivalence studies and Biowaiver justification.
MAH Services
The Marketing Authorization Holder (MAH) term refers to a company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States. MAH is the entity which takes the responsibility for ensuring compliance with the standards set out in European Union (EU) legislation and guidelines.
At Pharmaceutical Innovation Services, we can act as the Marketing Authorization Holder (MAH service) for your medicinal products.
We assist companies in registration procedure under national procedure, the decentralized procedure (DCP) or the mutual recognition procedure (MRP) while acting as the MAH.
We may also assist in commercial transactions of confidential sale or purchasing of marketing authorizations (MA) for each medicinal product, their dossiers or in any other case, when you need us to represent your company as MAH under our name.