About SARPHARMA

SARPHARMA specializes in the development of Medicinal Products, Regulatory Affairs, Market Access, Pharmacovigilance and Clinical Research.

Understanding of clients’ commercial needs, the main decision makers and the path to the market, we are able to recommend medicinal product development, regulatory market access, pharmacovigilance and clinical research solutions.

With the continuous support and outstanding efforts put in by our experienced professionals, we have been able to provide our clients the best quality services. Under this consultancy service, the best solution is provided to our clients in a prompt manner under the strict supervision of our experts.

SARPHARMA expertise covers regulatory affairs, market access, pharmacovigilance, clinical research and pharmaceutical development. Our goal is to help clients maximize the value of their product, device, cosmetic and food supplement throughout its development and lifecycle, creating innovative, regulatory strategies and solutions, tailored to the client, to achieve set milestones.

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Medicines
Biologics
Orphan drugs
Medical devices
Food supplements
Cosmetics

Regulatory Affairs

SARPHARMA has a team of experts who can help you with any of the following topics.

We are proud to help and support customers not only with strategy, but also with implementation, which is the key to successful marketing.

Regulatory  Affairs strategy

  • Evaluate technical data (chemistry/manufacturing, preclinical, clinical), to determine the appropriate regulatory procedure and legal status for products
  • Head of the Scientific Service (RSS), training, compliance with national and regional regulations, approval of educational material and risk minimization measures (RMM) and advertising
  • Arrange and manage scientific advice meetings with regulatory authorities
  • Propose optimal submission strategy Establish frequent contact with regulatory authorities to facilitate compliance Regulatory management & implementation
  • Clinical trial applications
  • Dossier Preparation (CTD, eCTD)
  • Translation services
  • Submission process
  • Liasion with Health Authorities
  • Marketing authorization applications, management of the procedure, and Marketing Authorization holdership
  • Post approval maintenance
  • Variations, Renewals, Pre-Clinical Overview and Clinical Overview, Labelling review and approval
  • Preparation of price& reimbursement  dossiers
  • Evaluation of the impact of reclassification on product reimbursement and pricing

SARPHARMA provides  the appointment of the role of proxy with AIFA and other competent authorities Ministry of Health, Health Institute (ISS), Embassies, and other agencies regarding medical devices) on behalf of the clients.

Proxy Role:

  • Manage contacts with the competent authorities relating to   procedures regarding medicinal products;
  • Activate and manage contacts with the Ministry Health and   other regarding medical devices, cosmetics, food supplements;
  • Collect and transmit permits, requests and decrees on behalf of   the clients;
  • Prepare all correspondence and documents related to the role   and the activities of proxy;
  • Follow up of procedures pending with competent authorities,   and intervene with such entities, including by consulting and   comparing with the responsible officers for the resolution of   any problems and prevention of critical situations.

 

Regulatory  Affairs Strategy
Medical Device 

  • Strategic-regulatory consulting
  • Support for CE certification
  • Italian and European ministerial  records
  • International registrations outside the EU
  • Local Representative
  • Medical Device Vigilance and  safety assessment

Regulatory Affairs Strategy
Food Supplement

  • Ministerial notifications
  • Certifications with Recognized Certification Body (NB – Notified Body) and notification to the Ministry of Health
  • Food supplement Vigilance and safety assessment

Regulatory Affairs Strategy
Cosmetics

  • PIF and notifications
  • Lab test
  • Safety assessments and vigilance
  • Technical evaluations
  • Support  of compliance with Cosmetic Regulations

Small Medium Enterprises – SMEs

EMA

The European Union recognizes the key part that micro,  small and medium-sized enterprises (SME’s) play in the  innovation of new medicines and the benefit that these  provide for patients.

At the same time it acknowledges that  SME’s do not have the same resources as larger companies.

So in 2005 the EU introduced financial and administrative  help for SME’s.

We can assist companies with applications to achieve SME status and access the incentives available.

sarpharma

FDA

The Food and Drug Administration (FDA) is a large, complex  organization which requires a good understanding of which  processes are relevant to a specific project – this requires  FDA specific expertise for the different product categories. In the US we have local expertise and access to experts who  have this detailed expertise which includes:

  • Representing international companies as the designated  US  agent
  • Liaising with the FDA to resolve issues and expedite    marketing approvals
  • Preparing and submitting Drug Establishment    Registration/Renewals Managing and inputting study   information into the FDA  database of investigational   protocols for the treatment  of serious and life threatening   diseases

fda sarpharma

Market access

Understanding of clients’ commercial needs,  the key decision makers and path to market, we, together  with our partners, are able to recommend market access  solutions to help our clients bring their products efficiently  to market.

  • Product development strategy to ensure regulatory requirements are incorporated into clinical  programs
  • Liaise with Healthcare Technology Assessment (HTA) agencies
  • Development of HTA dossiers
  • Negotiations with the HTAs and insurers
  • Patient access and adherence programs
  • Regulatory guidance on branding

Pharmacovigilance System

Our Pharmacovigilance department specializes in the implementation and optimization of customized PV systems due Pharmacovigilance Inspections experience received by several European Regulatory Authorities. Together with you, we develop individual solutions to set-up the optimal PV system tailored to your company size/product portfolio. Our pharmacovigilance team also helps you to manage and monitor all routine safety aspects of your medicinal product(s). Together with partners in countries worldwide we provide you with country-specific PV services. Our services include:

  • EU-QPPV/-deputy function
  • Country-specific responsible persons for pharmacovigilance
  • Organisation of regional PV hubs
  • Pharmacovigilance quality system set-up and management (Quality Assurance including)
  • PSMF authoring and management
  • Post-marketing case processing management, including EudraVigilance reporting
  • Signal detection, PSURs , RMPs, Addendum to Clinical Overview, Medical writing
  • Local and global literature review
  • Screening of PV relevant webpages
  • GVP audits by certified auditors, vendor qualification, due diligence
  • xEVMPD management
  • Renting and management of Validated Safety Database
  • Pharmacovigilance training

PATIENT SUPPORT PROGRAM &
MARKET RESEARCH PROGRAM

Patient support programs (PSPs) and market research programs (MRPs) are popular and, in some areas, expected services of the pharmaceutical industry that place a significant burden on pharmacovigilance (PV) resources. PSPs are designed to enhance patient safety and help patients and/or healthcare professionals to better manage disease and optimize treatment. They include post-authorization patient support and disease management programs, surveys of patients and healthcare providers, information gathering on patient compliance, and compensation/reimbursement programs. As the number of patients that access drugs through PSPs continues to grow, it is important for PV professionals to be able to work with and provide oversight of those programs.

SARPHARMA is able to manage, plan and design of MRPs and PSPs and ensure compliance of Pharmacovigilance accordance with Italian and European legislation.

We are also able to design Digital Health Systems and related IT support.


Clinical Research

SARPHARMA offers multiple services for the management of all the stages of a clinical study .

SARPHARMA can efficiently  manage local (Italian) studies as well as  International clinical trials.

We support the Clients with maximum flexibility by managing the entire clinical trial process in all its aspects. Our highly qualified staff follows the sponsor from the planning of the initial activities, through data collection, management of the study, up to the final report.

SARPHARMA proposes itself as a «full service» business partner in the conduct  the following clinical studies:

  • Phase II-IV international studies;
  • No-Profit Studies;
  • Non Interventional Studies ( Observational and Registry Studies)
  • Studies on Medical Devices, Cosmetics and Supplements.
  • Digital en electronic therapies trials

Project and Data Management

  • Feasibility process and site selection for clinical trials: (phase II-IV) , Medical Devices, Cosmetics and Supplements
  • Medical writing and study protocol review and release
  • CFR drawing and design, both in paper and electronic format
  • EDC, IXRS, (e)PRO and patient diaries solutions (paper and electronic)
  • Central Laboratory solutions and vendor management
  • Preparation and management of all study related documents, including sites’ specific patient information sheet and Informed Consent form
  • Management of the whole authorizations process
  • Preparation and management of documents and «start-up» activities
  • Submission to Ethics Committees and Competent Authorities: management of all activities related the authorization of Ethics Committee and signing the contract with the institution itself
  • Investigators Meetings
  • Monitoring Activities (SQV and PSVs; SIV, SMV and COVs) including Centralized Risks based and remote monitoring (if required)
  • Data Management
  • Statistical Analysis
  • Final Report
  • GCP Audit at Clinical Centers

 

Pharmacovigilance Clinical Trial

  • Clinical trial safety officer/-deputy
  • Medical monitor for clinical trials
  • EudraVigilance responsible person for non-EU sponsors
  • SAE/SUSAR processing, reporting, and submission
  • Routine literature searches for on-going risk-benefit assessments
  • DSURs

QUALITY SYSTEM & COMPLIANCE

Whatever the size of your organization, our mission remains the same. We’re here to listen to your needs, monitor for the latest developments, and enforce our knowledge to deliver excellence in our quality and compliance consulting and services.

Achieving an optimal quality system which fullfils specific requirements,  your company internal  strategy and processes are mandatory for successfully  proceeding with high internal compliance and achieving the  required quality standards. Our team, supports you with any service that will benefit  your existing or intended system, according to ISO 900x, ISO 13485, ISO 180xx, ISO 140x or fulfilling GxP requirements.

Our services include:

  • Background information on the system requirements in the EU member states
  • Complete system set up or adaptation of your existing  system for a principal with several subsidiaries in several  EU member states
  • System set up or adaptation of your existing system for a  single company in one EU member state
  • Support during implementation of your  quality system
  • Training
  • Mock inspections and support during inspection preparation
  • Support during inspection
  • Support during follow up of authority inspections until  granting of the intended license(s)
  • Privacy regulation Compliance

sarpharma

Pharmaceutical Development

We can assist our clients in all aspects of development from  setting up and managing development plans through to  preclinical and clinical development and project managing  the whole process.

Our pharmaceutical development team has many years of  experience in all aspects of development and is able to help  you with any of the topics listed below:

  • Set-up of development plans
  • Follow-up and management of pharmaceutical development
  • Vendor selection and follow-up of vendors
  • Support in GMP requirements for the complete development program, including those for investigational medicinal products
  • Interaction with competent regulatory authorities as required during pharmaceutical development
  • Compilation of Investigator’s Brochures and IMPDs
  • Feasibility assessment & gap analysis for project assessment
  • Due diligence for in-licensing candidates
  • Dossier preparation (CTD, Technical document etc.)

Work Health and Safety:

  • Preparation of risk assessment documents and security plans
  • RSPP (Prevention and Protection Service Manager) and safety coordinators for any site
  • Compliance with ISPESL guidelines
  • Complete instrumental and environmental surveys for workplace safety
  • Preparation of emergency and fire prevention plans
  • Support and consultancy the environmental protection field
  • Liaising with competent vigilance authorities
  • Performing compliance of machines safety and standardization
  • Technical support for CE marking

Contact

SARPHARMA is the best and highest quality partner:

Regulatory affairs, market access, pharmacoviglance,  clinical  research  and pharmaceutical development.

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Call or contact us today, we’ll be more than glad to answer any questions you might have.

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