Progress Limited

Regulatory service:

In the dynamic, complex local regulatory environment and registration process, Progress Limited helps obtain swift marketing authorization for your products in Uzbekistan. Progress limited also facilitates existing product registration maintenance to ensure continued compliance. As CIS leading regulatory affairs consultancy, Progress Limited helps clients minimize compliance-related risk while saving time and resources.

Progress Limited consultants provide an extensive portfolio of professional regulatory services to support you through the lifetime of your product, and beyond. Experience with Uzbekistan, Russia and CIS countries health regulators and detailed knowledge of local requirements and procedures result in swift approvals for your license applications and regulatory submissions for:

Pharmaceuticals (Human and Veterinary)

Medical devices

Cosmetics

Food supplements

Homeopathic products

From large multinationals to small biotech firms, our regulatory affairs solutions are tailored to meet your exact requirements, from full regulatory affairs department outsourcing to filling appointed pharmacist or regulatory affairs functions to project management. We advance your products in the Uzbekistan and CIS market by ensuring legal compliance, resolving issues with the concerned Ministry of Health and keeping current with industry trends to advise on regulatory aspects affecting your objectives.

Regulatory services include:

Regulatory affairs service.

Qualified Person (QP) outsourcing

Appointed pharmacist / regulatory affairs manager out sourcing/in sourcing

New product approvals, dossiers, submission and follow-up for innovations or generics

Post-approval support (renewals, variations, import issues, etc.)

Labeling and Packaging with localization (patient leaflets, labels, packages, etc.)

Promotional materials/activities for public and medical community.

Business development, due diligence.

Management consulting.

Regulatory second opinions.

Pharmaceutical labeling and localization:

Progress Limited delivers added production value by providing end-to-end product labeling and localization. These services address all aspects of labeling from localizing material and translation to artwork/graphic design, to final printing. With extensive medical product experience, specialized knowledge of local regulations and exclusive focus on the local market, Progress limited addresses the complex packaging and labeling localization demands of the pharma industry.

Progress Limited best practice approach lets companies offload tedious and time-consuming labeling and localization tasks, to trusted experts who are meticulous about the out come. Labeling and localization services feature:

Adaptation and localization of written packaging materials to comply with current and new Uzbekistan regulations: Verification of labeling format, adapting materials to new leaflet formats and packaging requirements, etc.

Translating labeling, packaging content and related product documents. Localization into formal languages: Uzbek, English, Russian and other CIS countries local languages. Graphic design for packaging material artwork including pagination and layout, design of multi-lingual text and graphic elements (e.g. logos), adding barcode and pharmacopeia, and preparing deliverables in print-ready graphics files. Printing all packaging labeling using offset and digital print processes (as needed), supporting color ranges from multi-color to 8 colors, printing on a variety of label substrates and folding including booklet format.

Medical information services

Knowledgeable responses to healthcare provider and patient inquiries on your behalf—managed by skilled and sensitive medical professionals, which includes: Sharing product information, such as: usage, side effects, drug-drug interactions, disease applications and optimizing effectiveness.

Comprehensive contact center and reporting services.

Development of frequently asked questions (FAQ) database for company responses to medical inquiries. Supporting challenging products, such as those that are complex, controversial or have not yet gained market acceptance.

Marketing research of the market taking into account the competitiveness of the product. Searching and assigning the distributor for your company.

Efficiency analysis of sales by means of monitoring of sales of distributors, pharmacies and correction of steps into the market segments for sales promotion.

Support and supervision in organizing clinical trial of the products.

Organization of information campaign (seminars, meetings, lectures, presentations) among doctors, pharmacists, medical students, to promote the product and boost sales on the market of Uzbekistan.