www.productlifegroup.comPage 1 of 4

B R O C H U R E

ProductLife Group Delivers Complete High-Level Support of Regulatory Affiliate Activities and ProcessesWhat is local regulatory affiliate outsourcing?Bringing a product to global markets and maintaining it through its life cycle together present many challenges for life sciences companies. Not only must companies juggle various kinds of regulatory requirements; they also must ensure that product strategy gets integrated into the overall approach.

Local regulatory affiliate outsourcing removes those complexities from global companies’ burdens. Instead, a partner with global and local regulatory expertise handles all activities with regard to national competent authorities’ requirements as well as all of the procedures and activities associated with each product in each country or region—from planning to tracking.

During the outsourcing relationship, the partner takes on progressively more responsibilities, including:

• Regulatory-activities-planning management• Performance of local regulatory tasks• Management of all portfolio-related activities• Advice on regulatory procedures and country or regional tactics

www.productlifegroup.comPage 2 of 4

GlobalRegulatory Affairs

Activities

LOCALREGULATORY AFFILIATE

OUTSOURCINGA single partner for all activities

Local Regulatory Affairs Activities

BUILDING TRUSTED, STREAMLINED PARTNERSHIPS—FROMCORPORATE TO AFFILIATES OR LOCAL REPRESENTATIVES

PremarketingInitial (or baseline)

submission

Life cycleevolutions

Postmarketingchanges

Regulatorylife cycle linkedto procedures

with predefinedmilestones

Associated Procedures

Product Regulatory Portfolio

Regulatory-activity planningper product andper countries/

regions

Country 1• Execution of

local activities• Exchanges

with national competent authority (NCA) (Q&A)

RegionCountry A• Execution of local activities• Exchanges with NCA (Q&A)Country B• Execution of local activities• Exchanges with NCA (Q&A)

Country N• Execution of

local activities• Exchanges

with NCA (Q&A)

GLOBAL TASKS OUTSOURCING

PLAN EXECUTION OUTSOURCING

COUNTRIES TASKS OUTSOURCING

www.productlifegroup.comPage 3 of 4

The ProductLife Group differenceProductLife Group brings 25 years of experience in regulatory and pharmacovigilance to deliver end-to-end local regulatory affairs (RA) outsourcing across 127 countries.

ProductLife Group has established a streamlined delivery organisation that enhances the affiliate outsourcing process. A programme manager handles oversight, planning, reporting, and client interaction. At the hub level, a team of RA professionals provides local RA support and expertise, with responsibility for quality and deliverables. Our platforms are operated by a team of professionals who handle global RA and regulatory operations activities that span CMC writing, medical writing, dossier compilation and publishing, and labelling services.

To ensure seamless outsourcing, we developed a phased approach to our local regulatory affiliate outsourcing offering, starting with project scoping in order to understand clients’ needs and processes, to develop a setup, and to manage preparation, all of which is followed by a pilot and which then moves to a routine phase involving the implementation of all agreed tasks and processes. And we ensure ongoing successful relationships with each individual client through a process-based, customer-specific governance and change management approach in addition to following a system of well-defined key performance indicators and metrics.

Local partners are important parts of our global RA platform but with a key difference: we remain accountable for all partner deliverables; we are responsible for partner qualification and continuous assessment; we manage all partner activities; and we remain the client’s main contact. Our partners are responsible for executing assigned local RA tasks, submitting via the local portal, and providing regulatory advice based on local expertise.

Governance and Programme

Management Excellence

Regulatory Tasks Delivery

International Footprint

Regulatory and

Outsourcing Expertise

ADVISERS

PROGRAMMEPROJECTMANAGEMENT

HUBSHUBS ANDPLATFORMS

WE ENSURE ONGOING SUCCESSFUL RELATIONSHIPS with each individual client through a process-based, customer-

specific governance and change management approach.

ProductLife Group specialises in helping international life sciences organisations more effectively get their products and therapies to market by providing those clients with functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing.

Performing successfully for more than 25 years, ProductLife Group has an established global presence in Europe, the Middle East, Asia Pacific, Africa, Latin America, and North America. We deliver services via an innovative, platform-and-hub operating model, enabling our clients to achieve continuous improvement, increased quality, enhanced performance, reduced risk, better compliance, and overall cost benefit. That approach, combined with our collaborative, partnership-oriented culture, empowers life sciences organisations to realise the commercial potential of their own international operations.

www.productlifegroup.comPage 4 of 4

High-level benefitsProductLife Group’s team of regulatory, pharmacovigilance, and medical information experts within our hubs and platforms enables us to provide high-level strategic and tactical support with regard to many aspects, such as:

Product, procedure, and country

or region

Scientific and regulatory

interactions with health authorities

Content writing

Process adaptation and change

management

Process and information

systems management*

Integration of technology-enabled task automation

Regulatory intelligence

*Including regulatory information management systems; the Identification of Medicinal Products; and substance, product, organisation, and referential data.

ProductLife Group has a verifiable record of success in delivering for clients, in meeting timelines, in producing high-quality submissions, and in helping clients achieve their objectives. Our key performance indicators include (1) meeting the evaluation of regulatory submission timelines 100% on time; (2) information collection, application content, and quality 95% right the first time; (3) zero recalls and zero complaints on packaging material; (4) translation input 100% accurate; and (5) regulatory intelligence delivered within a maximum of 15 working days with 100% of regulatory intelligence alerts within timelines.

NINE STEPS IN A SUCCESSFUL OUTSOURCING JOURNEY

STEP 1Set objectives

and expectations

STEP 2Ensure engagement

by both sides

STEP 3Establish

governance

STEP 4Define processes and clear lines of

responsibility

STEP 5Specify

deliverables

STEP 6Share

information

STEP 7Create transparency

and build trust

STEP 8Implement strong

change management

STEP 9Stipulate key

performance indicators