Regulatory Services

Our experts at Pharmazet understand the complex environment of Regulatory Affairs and are fully versed with the requirements of regulatory authorities across the world. Our teams recognise the ambitions of companies needing to drive their product portfolio to get products to market. We ensure that our team are trained and keep up to date with advancements in technology as well as the latest EU/US legislation giving them the strategic edge to meet deadlines and restrictions imposed by local and international regulations, having proven successful records of finalized centralized registration , DCP, MRPs, national of wide range of product starting with biosimilars, vaccines to generics or OTC products, fast approvals for medical devices to notification of food supplements or cosmetics .

We can manage every phase of a product’s life cycle:

  • Provide Regulatory affairs strategy for your product portfolio
  • Comprehensive advice on the impact of emerging and existing legislation
  • Provide appropriate submission route for your product (national, Decentralized, Mutual Recognition or Centralized) utilising EXTEDO software for eCTD compilation and publishing
  • Experience translations specialists with broad technical knowledge
  • Artworks and labelling
  • Publishing

Reach

The European chemical regulation REACH entered into force in June 2007. As a consequence, REACH companies using raw materials and other chemical substances, as part of preparations or articles need to take actions to secure their supply and use of these.

If you are a company manufacturing and importing substances into EU, you will have to register the substances at the chemical agency in Helsinki, Finland. We provide a very in depth support in this area from

  • REACH Consulting
  • REACH Registration
  • Late Pre Registration
  • Registration (Joint, Inquiry, Lead, Intermediate)
  • REACH Analytical & Technical
  • CLP Regulation
  • Safety Data Sheet
  • Label
  • SVHC (Substance of Very High Concern)
  • Authorisation
  • Restriction
  • SIEF & Consortia Management

PharmAZet REACH advisory services are commercially and technically qualified to undertake any complex regulatory challenge, including:

  • Assessment of REACH on business (obligations, benefits of investment towards registration, market analysis)
  • Project Strategies (Identifying the most cost effective registration process and estimating time for project completion)
  • Examining and facilitating all other regulatory requirements.
  • Communication on hazards, usage of substances along the supply chain (manufacture, importer & downstream user)
  • Impact of regulation (methods of production, substance use as an intermediate, guidance on exemptions)

REACH will affect the chemical sector and beyond. If the necessary preparations have not been made, the implications on companies can be significant.

Regulatory Affairs Strategy

The level of investment required and inherent risks in development of today’s new and advanced biopharmaceutical products are greater than ever posed in the history of the industry. Pharmaceutical products are more specialized, technology is more complex, the regulatory environment more tortuous, global markets for these products are more competitive and return on investment may be uncertain at the early stages of product development.

A Regulatory Strategy is essential as part of today’s biopharmaceutical product early development planning.

Our Regulatory Affairs Strategy is tailor made and includes a detailed regulatory procedure plan, covering an individualised product portfolio for each client with costs and time frames.

PharmAZet can aid from devising an effective strategy to providing hands-on regulatory support, our team of experts will identify the critical issues, ensuring you will get comprehensive advice, on how to address common regulatory hurdles, and clarify the impact of emerging and existing legislation.

Addition to this we also provide support and guidance on product life-cycle planning and management scenarios, including:

  • Risk management planning
  • Response to agency queries
  • Agency meetings
  • Advisory committee preparations
  • Scientific advice and protocol assistance

New Filling Service

With the ever growing complexities and changes to legislations, filing applications correctly is becoming an unnerving task. At PharmAZet We will provide comprehensive resources and support for smaller procedures, or for the management of the entire cycle.

Our team is highly experienced with filing of applications from simple compilation of application forms through to obtaining marketing authorization.

Our services include:

  • Abridge applications for generic products
  • Bibliographic applications
  • National, Mutual Recognition, Centralized and Decentralized Procedures
  • Variations to marketing authorizations (including Type I and Type II variations for marketing authorization updates)
  • Renewal of marketing authorizations in the EU
  • CMC & Quality Assurance Compliance
  • 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
  • Batch release and analytical testing for batches
  • Warehousing

Post Marketing Support

  • Comprehensive case management
  • Data entry, narrative generation and quality control
  • MedDRA Coding of adverse events (including regular up-versioning)
  • Follow-up on information inquiries
  • MedWatch/CIOMS report generation
  • Medical Review (including MedDRA coding reviews and trend analysis) by PV trained physicians
  • Expedited reporting in the EU
  • Follow up case processing and case closure
  • Periodic safety reports
  • Reconciliation of Adverse Events with business partners and the Quality Assurance group
  • Review of Global Safety Agreements
  • Literature reviews
  • Risk management

CMC & Quality Assurance Compliance

  • 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
  • Batch release and analytical testing for batches
  • Warehousing

eCTD Publishing

eCTD was introduced in February 2002 and developed by International Conference on Harmonisation (ICH). The European Medicines Agency began accepting eCTD submissions in 2003.

Our eCTD and submission publishers have created submissions for some of the highest profile products at several of the world’s largest Pharmaceutical companies, so you can be rest assured that your work will be in the most capable of hands.

Centralised, Mutual Recognition and Decentralised Procedure or National Licenses. MAAs, Line Extensions, Variations, PSURs, Paediatric Submissions, Referrals, Scientific Advice or Response Dossiers. eCTD publishing, submission publishers, NeeS or Paper Output – PharmAZet based publishing team has the skill and experience to ensure that your submission is published to the highest standards. Our work will always undergo a rigorous QC process using a variety of validation tools, ensuring that our output is always 100% compliant.

PharmAZet offers a range of services to suit a wide variety of needs – whether it’s our remote publishing service, eCTD publishing, business process consultancy, regulatory operations consultancy or training services – we’re certain to have the solution to your publishing and Regulatory Operations requirements.

Scientific & Medical Writing

PharmAZet experts have diverse scientific knowledge and extensive experience of pharmaceutical development to produce clear and concisely worded documents for medical and pharmaceutical companies worldwide. Based on our industry experience and regulatory interactions, we are able to prepare a diverse range of medical and pharmaceutical documentation to address the needs of your organisation, including:

  • Preclinical study reports
  • Clinical study reports (Phases I to IV) compliant with ICH E3 standards
  • Clinical protocols
  • Investigator brochures
  • Investigational Medicinal Product Dossier (IMPD)
  • Informed Consent Forms
  • PSURs
  • Narratives
  • Submission modules (CTD Sections 2.4, 2.5, 2.6, 2.7, 4 and 5)
  • PILs and readability questionnaires
  • EEC dossiers
  • Expert reports
  • Monographs
  • Scientific and protocol advice

Readability Testing

Since the end of 2005, it is a legal requirement within the European Union to perform readability tests on the Patient Information Leaflets (PILs) that are provided with all medicinal products.

If it is just one patient information leaflet or you need testing of a whole product portfolio, PharmAZet has trained teams within selected EU Markets of interviewers and developed a database of test persons which accurately represent all relevant groups of the population in terms of age, gender and education.

We aim to provide a fast and cost effective readability testing from complete user test to bridging reports.

  • EFPIA General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use
  • MHRA Guidance on the user testing of Patient Information Leaflets
  • EU Commission guidelines on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use

Marketing Authorisation Holder Services

MAH services is a complex task where you can be absolutely sure that in case of PharmAZet a team of experts ensure that EU QP PV/Deputy of EU QP PV, medics, RA Specialist, QA Specialist, EU BRS and all other essential functions are in place to provide you with tailored made services to address exactly your business needs for as long as you require.

We are also preferred service provider in area of RA and PV by many leading distributors so support with marketing of your product if required can be also provided.

Artwork & Labelling

Packaging artwork is an often forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore.

PharmAZet has a strong team of skilled professionals who deal with artwork and labelling support to offer everything from mock up designs, Blue Box requirements, a detailed linguistic check of the printed materials, Braille, to approved ready/print artwork. All this is conducted in a comprehensive yet cost-effective manner, to ensure your needs are thoroughly met.

Whether you need to implement Braille on your packaging and are looking for a cost effective solution for one or more markets, PharmAZet can provide you with tailor made solutions as our expert knowledge of current legislation is key to ensuring that you use all commercial advantages.

Whatever your requirements are, from a virtual artwork department to additional support of our packaging team, we always ensure that Mock-up and specimen requirements have been substantially reduced, still acknowledging the importance of printed packaging materials for the correct and safe use of medicines.

Translations

Accuracy, clarity, and consistency form the cornerstones for translation in the pharmaceutical industry. The reasoning is clear: consumers and healthcare workers rely upon product packaging to guide them in making the right product choice and in using pharmaceuticals properly. Without exaggeration, an error in either of these areas could mean injury, death, and years of legal fallout.

As an international pharmaceutical translation provider, PharmAZet translators have very specific knowledge vast experience in this subject area, whilst using cost effective tools as CAT is now common practice.

We have a host of certified pharmaceutical translators dedicated to providing the most accurate translation services who can ensure you produce correct and exact information about your products.

Our pharmaceutical translation experts are ready to take care of all your pharmaceutical needs, from translation from one EU language to complex coverage of 27 EU national labelling, we are here to provide you with fast and reliable support

Medical Devices

Our experience does not solely lie within just pharmaceutical, we also have extensive experience assisting medical device and IVD companies with international and quality assurance issues. With our support you can obtain regulatory clearance, maintain compliance, and increase your sales in the fast growing medical device market.

Whether you’re entering the EU market for the first time, or introducing another device, we can assist with everything from ISO 13485: 2003 Quality System compliance and audits to Design Dossiers and even conducting Clinical Trials.

Our team of experts will advise you on which EU directives will apply to achieving CE markings, and on the appropriate device classification and related regulation and registration requirements, and support the implementation of a quality management system that complies with ISO requirements.
We can also act as a regulatory Authorized Representative to non EU manufacturers without a local office in an EU member state.

Food Supplements

With the increasing availability of food supplements, natural health products and complementary medicinal products on the market today, regulatory authorities are requiring greater standards to ensure that the public has access to products that are safe, effective, and of the highest quality.

PharmAZet global experts have an unparalleled understanding of the intricacies and processes of regulatory agencies and the requirement to develop a successful strategy, follow through with the submission process, and act as a liaison with regulatory agencies as required by our clients.

Cosmetics

A new approach to chemicals legislation in the EU with REACH. Chemicals placed on the EU market – be it as such or as part of a finished product, need to be registered with a safety data package and a human and environmental safety assessment. Cosmetic ingredients are covered by this registration obligation

PharmAZet provides comprehensive regulatory advice concerning all areas of cosmetics regulations. Although legislation can vary widely depending on region, we have the global expertise to provide the highest quality service, wherever it is required.

We can also provide you with reliable and certified manufacturing sites within EU or Asia to streamline your profitability.