Freyr now offers strategic medical writing services across a spectrum of domains to the global biopharmaceutical industry. Freyr also provides a full range of writing services in medical writing that include writing scientific documents of diverse nature covering all regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles.

Freyr also offers end-to-end medical writing services to clients in pharmaceutical and medical device industries.

Freyr’s services include:

• Writing/editing of regulatory submission documents
• Consulting and training
• Document template solutions

Freyr is uniquely positioned to provide best-in-class services based on similar successful partnership experiences, therapeutic area expertise, and delivery rigor. Freyr’s medical writing associates have extensive experience in medical writing & publishing for more than 120 studies across a broad range of therapeutic areas.

Freyr announced the launch of new medical devices regulatory services designed to provide a focused, market-driven approach to ensure compliance with global regulatory requirements. The new service offers an effective regulatory strategy to medical device companies to gain competitive edge in meeting the regulatory requirements.

In addition, Freyr provides end-to-end services starting from device classification to market approval which includes appointing legal representative and offering guidance in attaining certifications like QMS etc.

Freyr will assist in navigating across any regulatory issues and offers a path to approval across multiple jurisdictions through implementations of a strategic plan in registering the device for different agencies which makes the approval process easier. Freyr’s specialized services will enable the device companies efficiently address the increased scrutiny from national regulatory agencies while minimizing downstream risks.

In the current regulatory climate, most of the Pharmaceutical companies are struggling to maintain research and development (R&D) productivity. Pharma companies are keen to explore new drug development models which can cut development costs, accelerate timelines and still maintain quality and compliance.The swift turn to modernize their development operations is partly to do away with obsolete models of development in particular, in-house technology solutions that will in turn offset slowing growth rates to achieve bottom line results.

REGULATORY INTELLIGENCE IN EMERGING MARKETS

Emerging markets in Asia Pacific, Latin America and Eastern Europe are increasingly important locations for drug development as sponsors pursue multinational programs to gain access to appropriate patient populations. Emerging markets which have been termed as the promised land, account a third of the global pharmaceutical market by 2016. The markets are a hot bed of huge populations, increasing prosperity and improving longevity, another positive aspect.

There are three main clusters the BRICMT economies (those of Brazil, Russia, India, China, Mexico and Turkey), second-tier countries such as those of Southeast Asia; and finally Africa. Companies must balance their global competences with tailored approaches for regulatory intelligence functions for these emerging markets. Regulatory intelligence functions must be structured to define market-tailored and effective business strategies for each market segment which will allow companies to avoid losses in terms of revenue and commercial viability.

RI GROUPS: PAIN POINTS

In the 2014 survey about a centralized RI program, customers place high value but low satisfaction on the products of the RI group. The central RI program is usually located at the company headquarters and is managed by a relatively small staff with additional staff employed for a major market alone

• Work of the central RI group is often relatively broad coupled with the critical mission tasks. Small staff caters to diverse missions that cover both hard and soft intelligence
• Rising requirements for information and inspections by Health Authorities 67% of the companies established a centralized regulatory intelligence office/program
• A quarter responded with a “yes” when asked if the centralized RI program is viewed as the authoritative source for hard and soft intelligence services
• Only 1/3 responded that their RI program is the authoritative source

CONCLUSION

All companies perform regulatory intelligence to some extent and more companies are establishing dedicated intelligence groups. Regulatory intelligence scope does vary in form of active analysis and interpretation, however it does not equate to regulatory information. Furthermore regulatory intelligence is imperative along with allocation of key tasks to ensure compliance, future awareness and adequate resourcing. Benefits of having the correct regulatory information will enable to design and implement a good regulatory strategy which can lead to reduced time to market both via accelerated development and smoother registration assessment, reduced costs, increased compliance and ultimately optimization of return on investment.

• Provide strategic regulatory intelligence services for a $17+ bn global consumer products company
• Creation of a comprehensive regulatory intelligence report for several product categories (Oral Care, Personal Care, Household Care and From The Dentist) in the client portfolio across target markets including Africa, Middle East, LATAM and Asia
• An updated RegInsight platform, Freyr’s Regulatory Intelligence Portal, will deliver the client with regulatory strategies based on current regional guidelines

• Provide regulatory services including end-to-end dossier management, publishing and submission of key active API’s (DMF) for a $600+ Mn global South Korean Pharma client
• Undertake gap analysis and conversion of paper DMF to eCTD format and submission through Freyr’s electronic gateway
• Work towards improving regulatory compliance and enhance project delivery while standardizing regulatory operations

Creation, maintenance and updating the CCDS costs money to the MAH and requires lot of time and effort. Keeping the CCDS up to date is a continuous process, and as soon as significant new information is noted it should be reviewed for updating the CCDS.

The MAH has to submit the labels to the local competent authority and get it approved in the countries where they want to do business. After approval, this will become the official label for that country. The CCDS as per the ICH E2C (R1) is defined as “It is a common practice for MAHs to prepare their own “Company Core Data Sheet” (CCDS) which covers material relating to safety, indications, dosing, pharmacology, and other information concerning the product.

A practical option for the purpose of periodic reporting is for each MAH to use, as a reference, the safety information contained within its central document (CCDS), which will be referred to as “Company Core Safety Information” (CCSI).” The local label (SmPC or USPI) is the official label for a product in that country and is approved by its local health authority.

This local label can be a prescriber’s information, patient information or the label on the carton. Local health authority reviews and approves the label in accordance with its rules, regulations and guidelines. Hence, the final local label might have difference with the proposed label submitted by the MAH. Hence, the local label might deviate from the company position on a product.

HEALTH AUTHORITIES: LABELING TEMPLATE

Health authorities have their own template for the labels, which is different from others. For example, European Union Summary of Product Characteristics (EU SmPC) template has a section on “driving and using machines” and even if there is no relevant information available for this section the local label should contain this section explaining the same.

However, in the USPI or various other country labels this section is not a part of the template and the information related to driving and using machines would only be included in local label if there is enough evidence to support any impact (actual or potential) on the ability to do work which require alertness like driving and using machines, in that case this information can be added to the appropriate section e.g. the warnings or precautions section.

GLOBAL HARMONIZED LABELING

It is more important for the companies doing business in multiple countries and regions as
inclination to a local label template for the CCDS will pose challenges in having the harmonized labeling globally. The hybrid template can be a better option to cater the needs of all the countries globally.

It should be kept in mind while developing the hybrid template that it should contain all those sections which are related to safe use of the product and allows inclusion of the minimum safety information in the CCDS. However, the local label can still have any country specific information and any information mandated by the local HA.

CCDS: AN IMPORTANT GUIDE FOR THE PRODUCT PROMOTIONAL CONTENT

CCDS is not only used to create the harmonized labeling or for pharmacovigilance but it is also important guide for the product promotional content. It can act as a tool to control the promotional content centrally. To serve all the purposes discussed above the CCDS for any product need to be updated on the regular basis, and as soon as any new safety information comes to knowledge.

The new information should be added to the CCDS only if it has enough scientific evidences to support the inclusion and should not be driven or influenced by any business interest of the company.

This should be discussed in detail as the rationale for the CCDS update and should be authored by the well qualified experts. MAH should also ensure that their promotional material is in line with the labeling.

• Successfully provided in-depth market intelligence insights across 7 SSA countries
• Enabled competitive market selection and minimization of investment risks

BUSINESS IMPERATIVES

The scope of project is to generate the regulatory and market intelligence data for Pharmaceuticals for seven countries in Sub Saharan Africa region identified by the client – Kenya, Ghana, Tanzania, Zambia, Angola, Nigeria and South Africa

CHALLENGES

• Defining a streamlined process
• Identify information related to regulatory process across and within individual countries
• Creating new templates for developing the regulatory and market intelligence in Sub Saharan Africa region
• Identifying the competitor companies, products & pricing
• Study of market distribution policies

CLIENT BENEFITS

• Identification of new opportunities
• Early warning of competitor moves
• Minimizing investment risks
• Better market selection & positioning
• Quicker, more efficient and cost effective information

FREYR SOLUTION & SERVICES

• Preparation and sharing of table of contents for the intelligence report
• Preparation of pharmaceutical regulatory and market intelligence report template
• Report generated based on the finalized content
• Analysis and finalization of the applicable and relevant content related to
  • Pharmaceutical industry view
  • Regulatory process: country specific
  • Competitor companies and their products