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A-pharmaconsult Regulatory Support
A-pharmaconsult is a specialist in quality and regulatory affairs that can provide a full range of regulatory consultancy services, includes acting as a Regulatory Affairs partner, helping life sciences companies ensure regulatory compliance and bring products to market.
Regulatory affairs in the pharmaceutical industry
The modern pharma industry is driven by the imperative to assure patient safety, with global regulatory affairs determining drug and medical product life cycles. With products, from early stage development to post-marketing maintenance and transitional safety, medical regulatory affairs pose key challenges, with more than ten per cent of all inspections carried out in some European countries resulting in findings of non-compliance, causing delays at the very least.
The A-pharmaconsult team includes professionals who are highly versed in all relevant clinical, medical and scientific regulatory affairs fields with in depth experience in regulatory compliance consultancy.
A-pharmaconsult works across Europe in both clinical regulatory affairs and also medical device compliance, serving the needs of pharma and life sciences organisations of all kinds, ranging from mature organisations to start-up groups.
European Regulatory Affairs
Appropriate regulatory affairs strategy and knowledge are critical to determining which filing procedures are applicable for relevant EU or European Economic Area (EEA) markets, extending to effective dossier preparation and efficient regulatory submission to speed time to market.
A-pharmaconsult helps clients with regulatory submission of all modules of the MAA Dossier; including writing of common technical document (CTD) and electronic technical document (eCTD).
Its regulatory affairs service includes:
- Dossier development:Detailed assistance with regulatory strategy development as well as writing and preparation of dossier modules to make sure that all regulatory requirements are fulfilled. Its regulatory affairs consultants can use gap analysis to identify issues to be resolved pre-submission.
- Medical writing: A-pharmaconsult’s specialist authors and content editors can help prepare clearly written and accurate applications for regulatory submission to the relevant agencies.
- Regulatory Submissions and Procedural Management to support regulatory submissions.
Regulatory affairs in pharma
The A-pharmaconsult team of regulatory affairs specialists includes experts trained to Global Institute of Regulatory Affairs (GIRA) standards practical knowledge of regulatory agency procedures, inspections and audits, which makes them highly qualified to prepare for inspections, internal audits, vendor and supplier audits and carry out gap assessments.
The regulatory consultancy team can effectively work as part of a client’s Quality Assurance or Regulatory Affairs Department, working in close partnership to identify measures required for quality improvements.
A-pharmaconsult qualified auditors expertise covers the entire European regulatory affairs spectrum including cGxP, ISO Standards, CSV, and data Integrity.
A-pharmaconsult’s pharmaceutical regulatory affairs services include medical writing to assist in various aspects of documentation and regulatory submissions including: Technical writing and Quality Overviews, Writing of ASMF, DMF and CEP files, PSUR writing and submission, Drug product information (SPC, PIL), patient safety leaflets, advertising/labelling, proofreading and translations.
A-pharmaconsult fully understands the complexities of drug regulatory affairs from first drug development extending across all quality processes and CMC regulatory affairs. We can help to shape effective regulatory affairs strategies.
As part of its regulatory affairs services in pharma, the A-pharmaconsult experts can:
- Assess the pre-clinical study requirements per the indication
- Review and analyze the drug product development and advise on formulation development, analytical testing, and validations per EMA or FDA requirements
- Collaborate for the clinical study plan and design of clinical studies from Phase I through to Phase III
Regulatory Compliance Consulting
A-pharmaconsult offers the whole range of regulatory services required by pharmaceutical companies. Based on the strong technical and scientific, regulatory affairs expertise of its consultancy teams, it can conduct successful conduct Marketing Authorization Transfers to support M&A activities.
Its quality management and compliance experts can be involved in all aspects of product lifecycle management providing strategic regulatory consultancy related to compliance in every stage from development to product withdrawal.
Regulatory writing (pharmaceuticals, consumer healthcare, etc.…)
- Product positioning and regulatory strategy
- Literature search and documentation review
- Nonclinical Overviews, Summaries & Expert Statement (Modules 2.4, 2.6 & 4 – NCES)
- Clinical Overviews, Summaries & Expert Statement (Modules 2.5, 2.7 & 5 – CES)
- Switch core dossier, Export dossiers
- Regulatory Submission to the Health Authorities (National, MRP, DCP, International, etc.)
- Compilation of documentation for Marketing Authorization
- Preparation of Marketing Applications (New, Variations, Renewals, etc.)
- Compliance reviews and Deficiency reports
- Conversion/update into CTD/eCTD formats
- Management of variations, line extensions and renewals
- Reimbursement/Price dossiers
- User testing
- Due diligence
Medical Device Regulatory Affairs
A-pharmaconsult can also provide a full range of regulatory consulting services for the development and registration of medical devices according to MDR 2017/745 and guidelines, including:
- Expertise in classification and evaluation of your product
- Assistance to develop your product in conformity with EU standards
- Writing of technical dossier for Class I, II or III medical devices according to EU current regulations
- Notification to the competent Authority
- Writing and evaluation of product labelling
- Writing and evaluation of promotional material
Click on A-pharmaconsult Regulatory Affairs Services for further information.