Regulatory Compliance

A core service offered to the Healthcare Industry centres around the critical, but non-revenue generating area of Regulatory Compliance of its manufacturing activities.

It is a specific area of current regulator interest. Fundamental to the business and significantly labour intensive for industry, a comprehensive and customised service is offered by SKS.

A complete solution includes initial evaluation to define the scope and allocate resource, assembly and collation of registered particulars and related manufacturing details, difference analysis and assessment, evaulation of risk , remediation and resolution strategy and submission filing.

The root cause of regulatory non-compliance is often identified as an absence of robustness in the change control system, in addition to decentralised regulatory functions. Advice can be provided for rectifying or implementing robust change control processes to guarantee future compliance.

 

Due Diligence

Due Diligence is the act of reviewing information to ascertain the value of a potential investment.

In regulatory affairs this should be undertaken during a Merger and/or Acquisition, in purchasing of a new product/ portfolio, or whenever a Company requires the review of regulatory information to make a commercial decision.

Validation of regulatory compliance is therefore essential for those investors making the commercial decision to acquire or become involved with a product or portfolio of products (both pre- and post-licensing). SKS can provide assistance based on its exhaustive knowledge of regulatory compliance, formulation and manufacturing, quality standards and local market intelligence to ensure the right decision is made. As part of this evaluation, deficiencies and corrective measures will be reported, with estimated time and cost analysis.

 

CMC

Information regarding Chemistry, Manufacturing and Controls (CMC) for drugs is a specialised and comprehensive module of registration dossiers that support clinical studies and marketing applications.

A deep knowledge exists of the content and format of the CMC section for both drug product and drug substance, in relation to MA, post-approval submissions, ASMF, CEP and investigational applications. Support and guidance is provided for all CMC-based projects or dossier preparation, from individual sections to full CTD modules 2 & 3, in conjunction with all relevant ICH and regional guidance.

Both in-house experience and the access to a large network of suitable technical experts guarantees the highest quality documentation will be presented to regulatory agencies at all times.

 

Life Cycle Management

Life Cycle Management (LCM), is the implementation of optimization strategies to harness the total value of a product during its market journey, from its conception, through development and manufacture, to supply/use and disposal.

The pharmaceutical industry is evolving, and highly competitive. SKS can assist with the LCM of an existing product portfolio to help realise the value, for sustaining growth and profitability.

SKS will help develop and promote strategies to prolong a products life by investigations of reclassification, re-formulation, new forms or presentations, new indications or posologies and entering new market territories.

We can also assist you in steering through pharmaceutical industry guidance, for example on variation types and dossier requirements (Commission Regulation (EC) No 1234/2008, as amended), and advise on staying in compliance through a robust functioning Change Control System.

 

Post Marketing Maintenance

Post-marketing activities are a vital part of a medicinal product’s lifecycle. Extensive experience and knowledge is available to successfully support any post-licensing maintenance activities such as renewals, variations, patient-information updates and submissions, line-extensions, annual reporting requirements, drug-safety reports (PSURs) etc.

 

ASMF and CEP (CoS)

SKS has an in-depth understanding of the complex procedures associated with active pharmaceutical ingredient (API) registration in Europe through the ASMF or DMF, or via the CEP (Certificate of Suitability) procedures.

The general move of the pharmaceutical Industry to outsource API manufacture to suppliers in non-EU regions provides challenges that SKS can assist with, from interpretation of the EU regulatory landscape, discussions with the Competent Authorities, and preparation of dossiers for submission in the relevant format.

 

Regulatory Filings

Pharmaceutical products can be registered in the EU using a number of procedures, dependent on the type of drug and the intended route to market. European legislation provides for a centralised procedure, or through a national registration route or using the decentralised European procedures – Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP).

SKS offers European and International filing proficiency, irrespective of the product, submission route or target market. This includes registration via the following routes:

  • MAA (CP, MRP, DCP, National)
  • Line Extensions
  • NDA
  • ANDA
  • International Applications
  • Abridged Applications

From strategic considerations, to complete dossier compilation and filing, and to full life-cycle management, SKS can provide the desired solution.

 

Regulatory Strategy

Regulatory strategy involves the creation of a plan that results in the timely and successful placement of a product on the market.

It is not only selection of the right filing procedure, but also regulatory intelligence and choice of the target markets are some of the key components to a sound regulatory strategy.

It is essential to form the right strategy, first time, with involvement from all business stakeholders. This will guarantee compliance and an expedient time to market. SKS will assist you in developing the best strategy for your products.

 

Readability and Product information

Artwork and labelling have a significant role in the marketing of Healthcare products. The regulation of advertising, labelling and leaflet texts in the EU for prescription and OTC medicinal products are stipulated in Directive 2001/83/EC.

An important aspect of ensuring patient safety centres around these product packaging materials and their promotion.

SKS provides a readability testing service, which includes assistance with the design and layout of patient information according to Regulatory and technical requirements.

This involves an initial review and editing phase, development of testing protocols and questionnaires, recruitment of volunteers, interviewing stage, further editing and generation of submission-ready report. Bridging analysis and strategy can be developed to reduce the testing burden.

Support is also available in the preparation or review of company core safety information (CCSI) and company core data sheets (CCDS), as the basis for SmPC and labelling documentation in Europe and the US, and also education materials, if required as part of a Company’s risk minimisation activities.

 

Regulatory Intelligence

Rapid and efficient processing of regulatory submissions can lead to timely compliance, quicker times to market, or reduced costs of development. The benefits of excellent regulatory intelligence and strategy are therefore very clear. SKS can provide intelligence on optimal submission routes, legislation updates and potential hurdles, local regulatory market requirements, the current legislative framework, and competitor products.

 

Regulatory Writing

A successful regulatory submission requires a comprehensive understanding of and compliance with the regulatory requirements, adherence to the expectations of the Agencies, and the need for correctly presented information. SKS has significant experience in the preparation of the the CTD, modules 1 to 3. The involvement of Subject Matter Experts can also be necessary for the quality, safety or efficacy sections, which is made available through our network of consultants.

Assistance can also be provided to those Companies with older product lines with NtA dossiers to move to the eCTD format (for which a Company must have an appropriate validated document management system). Whether it be specific sections only as part of the Change Control Process, or the entire registration dossier including Quality Overall Summaries, this can be done in parallel with a full conformance quality assessment, to mitigate divergence from the manufacturing particulars.

 

Ask about our other services including:

  • Technical Transfer
  • THR Registrations
  • Nutraceuticals

Contact us for more information.