Solutions Gallery
by Role

Regulatory Affairs consulting supporting Product In-licensing, Product registrations, Product line extensions and major variations, Literature-based submissions and feasibility assessments. Prescription (NCEs and Biosimilars), Biotech, and Generic medicine registration, OTC and Medical Device registration.

Leading rapid-cycle, integrated evidence generation across HEOR, RWE, Phase IIIb/IV, and all other data, supported by microanalysis such as HTAs and systematic reviews to tailor information to the needs of specific issues of therapeutic/ marketing importance.

MetaWorks^® has an enviable track record in salvaging applications through full therapeutic category literature reviews and statistical analyses to provide new evidence and insights into current best treatment practices and patient management care options.

Global review of manufacturers’ incentives, Ultra/Orphan drug applications and regulatory submissions.

Client and competitive reviews informed by market research to determine market potential and economic viability of projects including: Product in-licensing, Product registrations, Regulatory response rejections, Government initiatives, New business initiatives, Repurposing established products.

High risk and complex projects integrating cutting-edge analysis and communications supported with the most robust and relevant evidence. Project examples include, Advertising to consumers, Removal of black box label warnings, contentious indications, white papers.

When you have deficient or complex data that is limited in its marketing application. MW has a long successful history in working with heterogeneous datasets integrating RWE and efficacy trials.

Including biostatistical analyses, epidemiological research, systematic reviews, healthcare resource utilization research, medical writing, promotional material review.

Implementation of successful defence strategies on regulatory matters such as industry code challenges/ defences, regulator responses, product cancellations, gap analysis of dossiers and data packages, identifying deficiencies for submissions, liaising with regulatory agencies, that may require high level expertise.

Vocational and tertiary Evidence-based skills technical training & Global Benchmarking of Employee Competence to enhance Regulatory personnel’s fluency in using evidence in shaping and delivering brand strategies and stakeholder messaging. Effectively further penetrating market verticals. Our programs are globally recognized award-winning qualifications, delivered through blended and advanced distance learning technology from one of the world’s top accreditation organisations.

Scoping and Rapid systematic review on areas of commercial enquiry such as expanded indications, licensing reviews, new data to motivate stakeholders (Drs, Reps), value assessments, bibliographic submissions, government initiatives. Delivering the Body of Evidence (BOE) towards your research and planning.

Includes development of evidential insights based on a review of the body of evidence informed by local market surveys of prevailing attitudes and opinions and gaps. Client objective is to identify the pivotal opportunities and recommendations that may shift product choice or prescribing behaviour.

To identify new commercial opportunities, new indications or to troubleshoot evidentiary issues such as the potential impact of government initiatives and impact of new entrants to market.            

Providing the necessary evidence-based ammunition including argumentation needed to call into check a recalcitrant direct competitor.

Facilitation of multi- disciplinary /department brand teams discussions to work through strategic issues and challenges.

Meta-Works excels at high risk and complex projects that often integrate cutting-edge analysis, communications and evidential education, supported with the most scientifically robust and relevant evidence. Project examples include, Advertising to consumers, removal of black box label warnings, registration of products with contentious indications, umbrella branding, rescheduling applications and collateral to boost sales force effectiveness in dealing with distribution channels.

Creating very effective evidential analysis and communications for initiatives such as:

• – Addressing prevailing objections and barriers limiting market acceptance and to shift prevailing attitudes and change market behaviour;

• – Proofreading and editing promotional materials;

• – Translating technical information into easily understood concepts and copy.

Vocational and tertiary Evidence-based skills technical training & Global Benchmarking of Employee Competence to enhance Regulatory personnel’s fluency in using evidence in shaping and delivering brand strategies and stakeholder messaging. Effectively further penetrating market verticals. Our programs are globally recognized award-winning qualifications, delivered through blended and advanced distance learning technology from one of the world’s top accreditation organisations.

Scoping and Rapid systematic review on areas of commercial enquiry such as expanded indications, licensing reviews, new data to motivate stakeholders (Drs, Reps), value assessments, bibliographic submissions, government initiatives. Delivering the Body of Evidence (BOE) towards your research and planning.

Addressing the clinical and economic evidence on alternative courses of action for new (and existing) medicines versus standard of care from a healthcare system perspective supported by microanalysis such as systematic reviews and adaptation of CE and budget impact models.

Identification of key local epidemiological and resource allocation data. Collapsing global models to substructures that can create the intended dynamic and iteratively test it against the original and give precise estimates of model parameters. Populating the simplified decision analysis models with probabilities, health state utility values, costs, and outcome data adapted to local life tables and local healthcare resource utilization.

Salvaging pricing submissions through sophisticated analyses to provide pragmatic workable options.

Including biostatistical analyses, epidemiological research, healthcare resource utilization research, adaptation of CE models and related data collection, medical writing.

Vocational and tertiary Evidence-based skills technical training & Global Benchmarking of Employee Competence to enhance Regulatory personnel’s fluency in using evidence in shaping and delivering brand strategies and stakeholder messaging. Effectively further penetrating market verticals. Our programs are globally recognized award-winning qualifications, delivered through blended and advanced distance learning technology from one of the world’s top accreditation organisations.

Scoping and Rapid systematic review on areas of commercial enquiry such as expanded indications, licensing reviews, new data to motivate stakeholders (Drs, Reps), value assessments, bibliographic submissions, government initiatives. Delivering the Body of Evidence (BOE) towards your research and planning.

Creating very effective evidential analysis and communications for a diverse range of initiatives such as:

• Addressing prevailing objections and barriers limiting market acceptance and to shift prevailing attitudes and change market behaviour;

• Proofreading and Editing promotional and regulatory materials

• Translating technical information into easily understood concepts and copy

• Clinical data and Expert Reports

• Business cases to government initiatives and regulatory evaluations & appeals

• Dispute counter-claims.

Providing the necessary evidence-based ammunition including argumentation needed to call into check a recalcitrant direct competitor.

Sometimes it is not what you have to say but how it is said and presented. Meta-Works are practiced communicators and presenters of scientific data. We recognise the value of understanding the local market context and nuances and addressing those key or pivotal points with well targeted communications.       

These studies establish how an area of activity contributes to the whole of economy effects – including GDP and employment – using methodological frameworks that are widely recognised and requested by public sector and Trade Association stakeholders. During these assignments Meta-Works deliver recommendations, studies, assessments, strategies and a final report that supports the client’s communications priorities and goals with holistic cost-effective data-driven methodologies.

Vocational and tertiary training programs to help medical and marketing & sales colleagues interpret statistics and clinical papers so that they become fluent in using evidence in shaping and delivering brand strategies and stakeholder messaging. Our programs are globally recognized award- winning a=d affordable qualifications, delivered through blended and advanced distance learning technology from one of the world’s top accreditation organisations.

Scoping and Rapid systematic review on areas of commercial enquiry such as expanded indications, licensing reviews, new data to motivate stakeholders (Drs, Reps), value assessments, bibliographic submissions, government initiatives. Delivering the Body of Evidence (BOE) towards your research and planning.

Pre-qualifying value through confirming; Existing pre- clinical and clinical data, scientific publications, likelihood of full regulatory approval, Achievable strategy to seek reimbursement in key markets, Robust clinical trial program to secure evidence supporting application, plus Key Opinion Leader (KOL) support, Clear milestones and deliverables for the program demonstrating success.

We work on complex industry problems with much of our activity concerned with drug pricing related issues. We also support research on the economic contribution of the industry through Socio- Economic Footprint studies etc. to have a better understanding of their impact and more accurately guide policy-making.