Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs & Operations

Regulatory Affairs and Operations Ensuring Product Safety and Regulatory Compliance

By partnering with an organization that understands the regulatory requirements and has the scientific and analytical background to process your information, you can be assured of the best support for your regulatory needs and optimal utilization of in-house resources so you can focus on bringing new products to the market and other core activities.

Our experts offer guidance and strategy to help clients understand and navigate the regulatory challenges that arise during the product development process. In addition, our vast regulatory experience spans across regulated as well as emerging markets and our understanding of the global regulatory environment allows us to help our clients deliver high quality and compliant regulatory deliverables for these markets.

With strong domain knowledge across pre- and post-marketing regulations and due diligence strategies, we can help you accelerate your products’ approval via:

• Custom reporting that reduces the chance of deficiencies

• Expert program/process management that helps you meet internal and regulatory agency timelines

• Quality deliverables that build the credibility you need to face regulatory scrutiny

The Growing and Complex Regulatory LandscapeIncreasing regulatory pressures, threats of litigation over real or perceived side effects, shifting demographic trends in regulated and emerging markets, weak pipelines, heavy competition and shrinking profit margins – these are just some of the challenges the life science industry is facing today. Furthermore, the increase in fixed-cost resources and the evolving responsibilities of regulatory affairs groups further challenges teams as they try to balance heavier workloads while the margin for submission errors narrows.

These challenges are driving organizations to significantly change and proactively adopt a regulatory affairs model that results in cost-efficiencies and refocuses staff time on core competencies and other strategic activities. Organizations are redefining corporate strategy via diversification versus specialization and turning to outsourcing vendors to help fill the gap and provide specialized services. This model allows organizations to focus on delivering excellence in its core business, while vendors deliver excellence in their services.

Delivering Quality and Excellence

By implementing proactive compliance that supports your company’s initiatives you will:

• Effectively launch and maintain product success in new markets

• Increase speed of new market approvals

• Extend brand formulations and indications

Sciformix offers strategic, technical and operational guidance throughout the entire product lifecycle, from filing of marketing approvals of new products and preparing for regulatory agency meetings and submissions, to supporting all post-marketing commitments.

Benefits

Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs & Operations

Preclinical Phase 1 Phase 2 Phase 3 Post-Approval

Global Regulatory Submissions

Clinical trial applications

Clinical writing

Patient narratives, safety profiles

Repurposing dossiers

Responses to deficiency queries

Briefing packages and submissions

Regulatory Writing

Product Labeling Management

Regulatory Strategy and Consulting

Supplements, amendments and variations

Quality Overall Summary (QOS)

Manuscripts and conference presentations

Sales and marketing material

Documents Specialists

Dossier Compilation, Publishing and Submission

Marketing authorization/drug registration applications

Non-clinical overviews and summaries

Creation and maintenance of global labeling documents and country-specific conversions

Labeling updates and amendments submission

Artwork preparation

Report and Component Publishing

Submission Management

Regulatory Affairs & Operations Portfolio

• 40+ years of cumulative experience in the development of regulatory strategy and submissions

• Knowledge across regulated and emerging markets for multiple therapeutic areas and varied product portfolios like pharmaceuticals and biologics

• Expertise in report authoring and submission management for early and late stage development, product lifecycle management

• Experienced pool in regulatory publishing and electronic submissions

Talent Tools, Methodologies and Assets• Expertise in accessing data from electronic

document management systems and tools

• Well versed in electronic publishing tools such as Docubridge, ISI toolbox and core dossier

• Regulatory intelligence and knowledge repository

• Innovation in the e2e labeling area is a workflow and content management engine; our global labeling managed services cuts errors, manual intervention and costs

Safety & Risk Management | Clinical Research & Post Approval Support | Regulatory Affairs

USA | UK | India | Philippines

Sciformix Corporation is a global scientific process organization (SPO) that partners with life science companies to develop, launch and sustain medical products that aim to improve the quality of healthcare worldwide. We collaborate with our clients through the entire product development lifecycle to provide a full range of services from study design to post marketing surveillance and commercialization support.

Trusted Services. Built on Science.Sciformix Corporation1500 West Park Drive, Suite 210Westborough, MA 01581 USAPhone : 1 (877) 576-5005Fax : 1 (508) 302-6520Email : bizteam@sciformix.com

www.sciformix.com