Services

Our collaborated partners & dedicated team of professional experts provides vast in-depth knowledge on the different steps in product’s life cycle managements, Pharmacovigilance, clinical research,  manufacturing facilities, market access, & translation of product information.

For every marketing authorization or product registration application is different & sometimes is a peculiar.

Please contact us so we can discuss your case in more detail.

Regulatory Affairs

Regulatory Affairs

eRA-Hub team of Regulatory affairs consultancy assist Pharmaceutical companies to plan & manage their pharmaceutical & medical device product regulatory requirements. Our qualified experts can provide consulting advice from pharmaceutical development to marketing applications.

  1. Dossiers preparation & assessment.
  2. Dossiers submission to other worldwide health authorities:

Submission in:

  • Europe
  • USA
  • Swissmedic
  • Health Canada
  • Australia
  • Turkey
  • GCC
  • Levant countries
  • North Africa
  • China especially medical devices & cosmetics products.
  1. eCTD & Electronic Publishing Services

Pharmaceutical companies choose to outsource all of their eCTD & Electronic Publishing needs to our team, while others seek our assistance on a project by project basis. eRA-hub team has experience of working on behalf of clients and managing their submissions to authorities. Our team can assist you in every aspect of your publishing needs. Feel free to get in touch with us today.

Free support, free update.

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  1. Product registration:

Different product type registration application preparation:

    1. Human Pharmaceuticals.

 Different product Submission registration application type:

      1. New Chemical Entity (NCE)-Originators.
      2. Generic drugs (GD).
      3. New drug-ND.
      4. Biological drug (BD).
      5. Biosimilar
      6. Radiopharmaceuticals.
      7. Herbal product.
      8. Vitamin & minerals
      9. Milk products (infants –complementary or special formula).
    1. Medical devices.
    1. Food Supplement.
    1. Special food.
    2. GSL (General Sale List).
    3. Cosmetic products.
    4. Disinfectant & detergent.
    5. Tobacco products (electronic cigarettes).
    1. Veterinary medicines.
  1. Liaison with regulatory agencies & assigns appointments.
  2. Preparation dossier for manufacturing site inspection & assign appointment with health authority.
  3. Develop regulatory strategy for product’s life cycle:
    • Consideration of international, regional & national regulatory requirements.
    • Renewal, variations, safety update etc.
  4. Respond to health authority questions.
  5. Assist with due diligence activity for investors/Licensees.
  6. Scientific & medical writing services.
  7. Labeling and packaging (patient leaflets, labels, packages, e Detailing. etc.).
  8. Translation of product information leaflet.
  9. Review of promotional material to comply with local health authority guidelines.
  10. Private label services.
  11. Technology Transfer files.
  12. Product development phases:
    • Pre-formulation studies phase
    • Formulation studies phase
    • Analysis phase
    • Stability phase
  13. Training
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Pharmacovigilance

Pharmacovigilance

We offer a complete range of vigilance services in Pharmacovigilance includes:

  1. Set up and implementation of Pharmacovigilance System, including writing/review of SOPs and preparation/maintenance of Pharmacovigilance System Master File (PSMF).
  2. Local Literature screening and review
  3. Authority Website Monitoring.
  4. Preparation of Risk Management Plan (RMP)
  5. Periodic Safety reports (PSURs/PBRERs)
  6. Pharmacovigilance audits (including preparation for audit/Inspection)
  7. Pharmacovigilance agreements/ SDEAs
  8. Reconciliation
  9. Training
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Drugstores & Distributors

Drugstore & Distributor Consulting Services

  1. Gap assessment & pre-inspection of facility
  2. Quality system establishment.
  3. Time and temperature sensitive product (TTSP) handling system establishment which includes:
    1. Good cold chain management practices.
    2. Good vaccine management system.
  4. Regulatory affairs services
  5. Storage facility design: Temperature / humidity mapping.
  6. Qualification/mapping/verification
    1. Cold rooms
    2. Fridges & vehicles.
  7. Validation for ice boxes & shipping containers.
  8. Software validation and alarm system validation.
  9. Sourcing and selecting of proper data logger monitoring & regarding devices for temperature/humidity system.
  10. Establishment for SOPs in compliance with current GSDP (Good Storage & Distribution Practices).
  11. Establishment of Organogram & job description preparation.
  12. Staff training.

Manufacturers

Manufacturer Consulting Services

  1. Regulatory affairs services
  2. GMP Preparation of :
    1. Preparation of conceptual designs as well as people and material flow inside different zones and departments on a basis of Good Manufacturing practices concept.
    2. Room and area specifications-Room Data Sheet (RDS).
    3.  Quality Systems and providing training on it.
    4. Provision of training courses in relation to universal GXP (GDP,GMP, …etc)
    5. Reviewing electro-mechanic design in compliance with requirements of cGMP.
  3. Auditing services (authorized auditor by IRCA)
  1. Gap assessment and auditing of customer activity, facilities, systems, and quality documents. The audit and assessments indicate weakness points, deviations, and suggested corrective actions.
  2. Provide solutions for problems pertaining to production machinery, engineering services and / or supporting units.
  1. GMP Construction includes:
  1. Exterior construction works (walls, stone, hangers and warehouses)
  2. Interior partitioning and installing gypsum boards and fabricated partitions (Clean room partitions) in a manner that achieves the required Room Classification as per the requirements of GMP, GDP and ISO14644 in terms of environmental safety and pressure differences in accordance with the set specifications that comply with local requirements as well as European and American requirements (Eudralex vol.4 and CFR21 respectively).
  3. Decoration works including painting, flooring, ceiling, entrances, dressing rooms, gypsum and other interior decoration works
  4. Construct, maintain and install systems of air conditioning and steam generation
  5. Provision and installation of processing and packaging machinery, supporting utilities, purified water systems, steam generation systems, compressed air generation systems, laminar flow cabinets, safety cabinets, weighing booths, and analytical/microbiological that satisfy the requirements of cGMP.
  6. Provision and installation of Laboratory furniture including cabinets for chemical and analytical labs as well as benches.
  7. Provision, installation, calibration and qualification of environmental monitoring and controlling systems in terms of temperature, humidity, particle counting and air circulation flow.
  8. Construct and install incinerators for disposing solid wastes in accordance with world environmental requirements and ISO14001
  9. Construction of calibration and qualification labs as well as provision and installation of all related equipment and providing training on them.
  1. Turn-key project

Clinical Research

Clinical Research

Establish setting rules of ethical and professional conduct of clinical trials in Jordan and in the MENA region to be in compliance with the international standards.

Market Access

Market Access

The main objective of each Pharmaceutical company is to launch and distribute its products on one or several national markets. Different markets have their own specificities regarding the distribution process, local representative needs, qualified representatives and applicable legislation at national level.

eRA-Hub network of companies can offer assistance to each Pharmaceutical company  to looking for qualified distributor partner, or to select best company to represent in your market.

Digital Technology

Pharmaceutical Digital Technology Transformation

eRA-Hub provides throughout collaborated partners a different scope of Digital technology transformation. Like Mobile communications, the cloud, advanced analytics, CRM system, Gamification, clinical research management and the Internet of Things are among the innovations that are starting to transform the healthcare industry in the ways they have already transformed the media, retail, and banking industries. Yet many find it hard to determine what initiatives to scale up and how, as they are still unclear what digital success will look like five years from now this includes:

  1. Customertimes Corp
  2. Viseven Europe
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Intellectual Property Rights

Intellectual Property Rights

We are aware of our clients’ needs, and therefore, our highly qualified experts and lawyers work with dedication to safeguard our clients’ rights and interests and provide them with practical solutions to protect and enforce their IPRs regionally and globally through a wide range of services:

  1. Trademarks
  2. Copyrights
  3. Patents
  4. Domain Name Disputes
  5. Franchise Agreements