Pharmaceuticals
At SRS we offer a wide range of regulatory affairs and quality assurance services for you and your company. Our professional consultants have many years of experience and are able to offer the assistance as you need it.
Regulatory Affairs
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Product Registration
Our expertise in international regulatory affairs and understanding of the requirements in the Nordics, ensures that we can help you device an optimal regulatory strategy for your new innovative drug, combination product, generic medicine or line extension.
Life Cycle Management
Besides pre-marketing activities such as MA applications we offer services within the area of post-marketing life cycle management to make sure your product is compliant with current rules and regulations and maintained and developed in the best way possible. This includes variations of different kinds, renewals and other procedures. SRS are well orientated in the Swedish as well as the Nordic regulatory landscape.
eCTD Submission
eCTD submission is a mandatory process and SRS provides the following services:
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Conversion of dossier documents to Common Technical Dossier format (the CTD format)
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Regulatory Submissions in the electronic (eCTD) format to the Health Authorities
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End to end services: publishing, submissions, and archiving of dossiers or submission sequences
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Delivery systems for all types of electronic submissions
MAH Services
We act as marketing authorisation holder (MAH), managing marketing authorisation applications in national and MRP/DCP procedures to approval, with continued assignment for, amongst others:
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Launch and continued marketing of the product/s, taking care of all regulatory requirements
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Later transfer of the product/s to a new MAH, as part of regulatory strategies
Regulatory Strategies
SRS offers assistance with life cycle management, new product applications and MAH strategies, facilitating formulation of plans to ensure that all processes are aligned.
Our team of experts supports our customers in prioritising of processes and optimizing of costs to increase efficiency of applications and maintenance of products on the market.
Additional Services
At SRS we also provide assistance with:
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Translations
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Review and approval of promotional material
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Readability testing
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Catalogue texts for all Nordic countries
Please feel free to contact me to discuss how we can support you.
Mail: Charlotte@srs.se
Phone: +46 8 121 326 71
Quality Assurance
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Based on your company’s specific needs and requirements, our consultants with years of experience can assist you both remotely and/or from your offices. Furthermore, we have our own GDP license at your disposal and can offer you PV support.
QMS - Consulting and Design
Keeping in-house quality management systems up to date with current regulations can be challenging. Our expert consultants can assist in deciding the elements and levels of Quality Management your company needs. We offer development, assessment and optimization of you Quality Management System based on company needs.
GMP/GDP Compliance
Our consultants ensure that your system remains in compliance with all processes of GMP and GDP, including but not limited to:
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Complaints - reception, documentation, investigation and response to complainant
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Deviations - implementation, maintenance of documentation, definitions, reporting and review
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Change control (CC) - initiation, execution and finalization of CC
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Recalls - support and execution of recalls
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Corrective and preventive actions (CAPA)
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Self-inspection
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Documentation
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Assistance in preparations and during authorities' inspections
Training
Our SRS team offers training in areas such as GDP, GMP and GVP based on regulatory requirements.
We can customize training to your needs, participants experience and your QMS:
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GDP training
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GMP training
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GVP (PV) training
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ISO9001 and ISO13485 training
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Internal audits
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Risk Management
SOP Compliance and Development
Authoring of SOPs is required for your quality system and GDP, GMP and GVP activities. We create and update operation frameworks and supporting documents to ensure that your procedures meet with the current requirements.
QP and RP Provision
Our consultants fulfil the Health Authorities requirements for acting as Responsible Person (GDP) and/or Qualified Person (GMP). QP/RP services are be provided full or part time according to your needs.
Audits and Supplier Control
At SRS we support with full audits, but also have the competence to aid with risk-based audit strategies, planning and execution of internal and external audits, preparation for and hosting of Health Authority inspections and follow-up until audit closure. Our experiences include, but is not limited to:
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Set up of quality/technical agreements
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Auditing, assessing and evaluating suppliers, manufacturers and wholesalers
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Performing internal audits
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CAPA management
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Follow-up of audit until closure
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Auditing of CMOs in India and other parts of Asia
Within our network SRS has qualified collaboration partners providing GMP audit services with local knowledge and experience in India as well as in other pats of Asia.
Pharmacovigilance
SRS provides PV support on a local level by assisting in building local PV systems and handling of suspected or potential PV cases. We have a great network of supporting contacts covering all of Europe ensuring that we can provide full EU PV support for our customers.
Please feel free to contact me to discuss how we can support you.
Mail: Marie@srs.se
Phone: +46 8 121 326 74