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Pharmaceutical Compliance Regulations

As pharmaceutical and life science companies come under increasing regulatory scrutiny, compliance has become one of their primary concerns. Governed by FDA validation, stringent quality norms and GMP, minuscule errors can put pharmaceutical companies at risk of product recalls, health authority warnings and fines. In this scenario, Vakils helps pharmaceutical companies deliver packaging artwork of the finest quality. What sets our artwork offering apart, is our focus on quality, with our average approval cycle being 1.2 cycles. This enables our clients to achieve faster time to market, lower costs, and to focus on growing their businesses.

Vakils works closely with clients and stays abreast with
changing legislations to produce highly accurate pharmaceutical artwork that meets corporate and patient design guidelines.

Our Experience

Vakils’ team of specialists undergo continuous training on information asset protection policies, good manufacturing practices and standard operating procedures. This enables them to create pharmaceutical artwork, which is compliant and of the finest quality.
We bring the experience of working across Europe, Asia Pacific, Australia, Latin America and the United States. We are the preferred partner to many Global Pharmaceuticals.

Vakils is an ISO 27001:2013 and ISO 9001:2015 certified company.

Our Services

Vakils’ offerings that are aligned for pharmaceutical packaging artwork (print and digital).

Vakils’ pharmaceutical artwork team works closely with our clients’ partners to follow defined guidelines including technical, non-technical and systems or tools to meet all customer expectations of lead-time, high quality and timely production.

Our experts support various supply chain activities through the workflow systems, including:

  • Designing of supply chain process flows (tools and manual) – artwork and regulatory management systems
  • Designing of artworks, packaging drawings and cutter guides
  • Quality inspection or quality reviews
  • Supply chain coordination support (pre or post artwork services)
  • Mockups and PGDTs
  • Innovative packaging and creative branding designs (including 3D samples)
  • Translations of content (multiple languages)
  • Pharma supply chain items integration.

Pharma Business Process Services (P-BPS)

Vakils supports a full supply chain of processes for the pharmaceutical business (strategic outsourcing). We link and customise multiple non-core supply chain activities, which could lead to improving our clients’ capacity and saving costs

Our P-BPS are as follows:

  • Centralised/decentralised pack services
  • Coordination of artwork supply chain services
  • Non-core regulatory coordination services
  • Regulatory compliance
  • Pre-artwork services (coordination between vendors/customers)
  • Post artwork services (pre-press and supplier tracking)
  • Product promotional services
  • SCI alignment of multiple sites/supplier services
  • Specialised expertise for global markets/localisation

Creative and Packaging Services

Vakils works closely with brands and agencies for end-to-end design and layout services. Our capabilities span the complete spectrum – from ideation to pre-print.

Our packaging services include:

  • Design and creative retouching
  • Use of specialised software to ensure accuracy and productivity
  • Proofing solutions for accurate print-ready files
  • 3D mock-ups and PGDTs

Localisation

Vakils has the experience and expertise in developing fully compliant branding designs, as per local regulatory requirements and current manufacturing guidelines, in various languages for multiple markets.

Regulatory Compliances:

Quality review primary and secondary labelling documents – CCDS, USPI, EUPI, CPPI, IFU, PI and Medication Guide

How Vakils’ Pharmaceutical Artwork Services Help Our Clients

How Vakils’ Pharmaceutical Artwork Services Help Our Clients
  • To make our clients’ experience seamless, we provide services across the full life cycle of a pharmaceutical product. We manage the end-to-end process utilising customised artwork workflows.
  • Vakils’ extensive knowledge of pharmaceutical requirements and needs results in our clients’ artwork amendments and change requests being completed quickly and accurately. Our goal is to avoid product recall and remove the need of multiple iterations in artwork, ensuring that products are fully QRD compliant with matching manufacturing manuscripts. By removing packaging compliance failures, we reduce time to market.
  • Our technical expertise in pharmaceutical artwork design and labelling, helps our clients develop and manage artwork for their products in various countries and in a variety of languages.
  • Vakils’ artwork specialists’ understanding of pharmaceutical legislation allows them to work in close partnership with our clients to produce final artwork that consistently meets corporate and patient design guidelines.
  • We help overcome counterfeiting and security issues by integrating text verification tools and pixel comparison measures to ensure patient safety.
How Vakils’ Pharmaceutical Artwork Services Help Our Clients

Our web-based platform for artwork management system manages pre and post-production specification, approval and version control through its lifecycle, including:

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Content Collation

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Artwork Creation

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Version Control

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Artwork Approvals

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Artwork Management

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Delivery and Distribution

Vakils Portfolio (Pharma Packaging Artwork)

Capabilities

Capabilities

Working closely in partnership with our clients, we have developed and honed our in-house processes and quality assurance.

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Capabilities

Product Samples