PHARMACEUTICALS

MEDICINAL PRODUCTS FOR HUMAN AND VETERINARY USE

• Provide advice on National, European and International legislation.
• Preparation of marketing authorisations applications for National, Mutual Recognition, Decentralised and Centralised procedures.
• Preparation of variations, extensions, transfers of ownership and renewals.
• Preparation of dossier in the NeeS format.
• SmPC, PIL and labelling with adaptation to QRD Readability test.
• Design of artwork for primary and secondary packaging.
• CMC, Clinical and Non Clinical overviews and summaries (Module 2).
• Compilation of Modules 3, 4 and 5.
• Notification of prices to the Health Authorities.
• Advise on promotion and advertising regulations
• Laboratory and facilities authorisation
• Relationship with local Regulatory Authorities

PHARMACOVIGILANCE

PharmaSolved can initiate and manage your entire Pharmacovigilance system. This option addresses the needs of companies looking for reliable and cost-effective drug safety solutions.

Benefits

• Regulatory and Pharmacovigilance expertise
• Focus on quality and technical expertise in our daily work.
• Our service concepts are flexible and we strive to match your needs.
• We work with reasonable budgets.
• Meeting deadlines is a priority for us.

European Qualified Person for Pharmacovigilance (EU-QPPV)

• European Economic Area (EEA) Qualified Person for Pharmacovigilance (& deputy QPPV).
• Establish and maintenance of Pharmacovigilance systems.

Local Pharmacovigilance Representative

• Local contact person for Pharmacovigilance (24/7 service).
• Communication point between the local authorities, local healthcare professionals, patients, client's sales force and client's Preparation of Standard Operating Procedures (SOPs).

Pharmacovigilance System

• Definition of Pharmacovigilance and Quality systems.
• Design and/or critically review of the Client's Pharmacovigilance system.
• Prepare, maintain and update the Pharmacovigilance System Master File (PSMF)

Literature Searches and Evaluations

• Continuous literature searches and evaluations based on active substances.
• Weekly or monthly searches available.

Pharmacovigilance Agreements with Third Parties

• Draft, review and update Safety Data Exchange Agreements (SDEAs).
• Establishment of clear communication channels and methods with partners.

Periodic Safety Update Reports (PSURs)

• Compilation, medical review, and submission of PSURs, addenda, and summary bridging reports.
• Risk Management System
• Preparation of Risk Management Plans (RMPs)

Training

• Pharmacovigilance Training for pharmaceutical sales representatives and/or company personnel

QUALITY ASSURANCE

At PharmaSolved the enhancement and continuous improvement of Quality is the responsibility of every individual. As part of our focus on our customers' compliance needs, we conduct surveillance of new regulations, and monitor and implement new regulatory trends. Leveraging our scientific expertise and proven track record, PharmaSolved provides regulatory support for chemistry, manufacturing and controls (CMC) and the quality assurance services essential during all phases of drug development, including process validation and marketing applications.

We acknowledge that it is essential to offer you a full range of service within our own facility thus we have also opened our own Batch Release site to provide you with access to the EU.

Our services include:

• Gap analysis and remediation
• Preparation of CTD modules 2 and 3
• DMF preparation
• QP services
• Import documentation and licensing
• GLP/GMP audit
• Pre-approval inspections – finish or API
• EUGMP/FDA CGMP
• Batch release (EUBRS) and analytical testing for batches
• Warehousing

HEALTHCARE SERVICES

Cosmetics

• Preparation of Product Information File (PIF)
• Preparation and maintenance of consumer information and product labelling.
• Notification procedures.
• Registration of products
• Responsible Person
• Request Free Sale Certificates
• Responding to consumer enquiries and regulatory objections
• Audits
• Cosmetovigilance. Set up a complete post-marketing surveillance of Serious Undesirable Effects. Reporting of Serious Undesirable Effects
• Cosmetic products safety assessment (safety report)
• Preparation of data sheets on the toxicological characteristics of cosmetic ingredients

Food Supplements

• Notifications, registrations and applications to Health Authorities – preparations, submission, and follow-up.
• Food labelling – preparation, evaluation, translation, and update.
• Technical support on the conformity of the labelling, composition and claims.
• Claims according to regulation (EC) 1924/2006 art. 13 and 14 – compliance, documentation, and submission.
• Design and development of packaging material.
• Marketing material – compliance, translation, and update.
• Request Free Sale Certificates.
• Audits.
• Phytovigilance.

Medical Devices

• Provide advice on current legislation in Europe.
• Verification of compliance of the technical documentation and the requirements for the registration of medical devices in Europe.
• Notification of medical devices to the Health Authorities
• Preparation of technical dossiers in order to obtain the CE mark. Contacts with Notified Bodies and consultancy for obtaining CE marking
• EU Medical Device Vigilance
• Act as the Authorized Representative
• Regulatory activities regarding the import/export of medical devices
• Translation and adaptation of the local labelling and leaflet in compliance with the relevant requirements
• Preparation of advertising material
• Request Free Sale Certificates

Herbal Medicinal Products

• Development and preparation of dossiers
• Assistance with the licensing or registration procedure
• Additional services, for example, readability testing, vigilance service.