Legal and accounting support for the production of medicines

 YOUR GOAL

You are planning to launch a pharmaceutical manufacturing facility, but there are many issues that need to be addressed.

Many companies prepare individual documents related to manufacturing, but each covers only a specific area, and you may not understand how to combine all these steps or whether they are sufficient to start pharmaceutical production.

Where should you start when launching such a facility? What action plan is required to open pharmaceutical manufacturing? Numerous questions arise:

• Whether your selected premises or land plot are suitable for pharmaceutical manufacturing — often no clear answer is available.
• Whether the chosen facility complies with pharmaceutical production requirements.
• What equipment is required for manufacturing, how it should be placed, and how to integrate it into production processes.
• How many employees are needed and what qualifications they must have.
• What tax burden will apply to the products.
• How to calculate the cost of imported raw materials.
• How to calculate manufacturing expenses.
• How to calculate the cost of pharmaceutical products.
• What markup can be added to production cost.
• How to calculate the total investment required.
• How much time is needed to launch such a manufacturing facility.
• And many other issues that form the overall basis for deciding whether pharmaceutical manufacturing is commercially viable.

To obtain clear answers and launch production with a full understanding of all risks and advantages, it is advisable to involve experienced legal and accounting professionals who will provide comprehensive support for your pharmaceutical business.

 OUR OFFER

Comprehensive pharmaceutical manufacturing support from registration to export

• Legal structuring: consulting and business planning; company registration; tax planning.
• Property matters: securing rights to real estate (lease/purchase); land allocation for construction; legalization of construction facilities.
• Technology and brand. Organization: development and registration of technical regulations; branding and trademark registration; packaging and labeling design.
• Design process organization: production facility or workshop design; obtaining construction or reconstruction permits.
• Technical equipment organization: supply of manufacturing equipment; procurement of construction materials; preparation of cost estimates.
• Construction and launch. Organization: construction works; technological installation; commissioning; facility commissioning.
• Permits and compliance: obtaining all required permits; implementation of quality and certification systems; implementation of industrial, fire, and environmental safety systems to open a pharmaceutical production facility.
• Personnel and training. Organization: production process training; occupational health and safety training; organization of accounting and HR operations.
• Automation and control. Organization: implementation of accounting and control systems; automation of manufacturing processes.
• Commercial activities. Organization: contract drafting; raw material import; export documentation; preparation for participation in tenders.
• Ongoing support: legal and accounting services at all stages of operation.

*The sequence and scope of work depend on the type of manufacturing, project scale, and characteristics of pharmaceutical products.

We provide a comprehensive approach to ensure that your pharmaceutical business operates efficiently, safely, and in full compliance with regulatory requirements.

Such important steps should always be taken with the involvement of experienced professionals to ensure a reliable start of pharmaceutical manufacturing.

 DOCUMENTS

Documents Required to Launch Pharmaceutical Manufacturing

• Copies of land plot documents: confirming the right to use or own land for the construction or expansion of manufacturing facilities.
• Copies of real estate documents (if reconstruction is planned): required to legalize premises and carry out construction works.
• Planned production volumes: allow assessment of equipment, raw material, and personnel requirements.
• Target sales markets (Ukraine or export): define certification, labeling, and packaging requirements.
• Estimated project budget: helps plan financial expenses and select optimal technologies.
• Product range: determines the need for specialized equipment and quality control systems.
• Target raw material procurement markets: define the need to optimize costs, reduce risks, and ensure supply chain stability.
• Technical regulations (if available): ensure product compliance with national and international standards.

Comprehensive preparation of these documents helps reduce risks, accelerate the production launch, and ensure compliance with legal and safety standards.

Entrust the preparation of all required documentation to our team — we guarantee fast and accurate processing while minimizing the risks of delays and inspections. With our support, your project will start without obstacles, and your manufacturing operations will fully comply with all legal and technical requirements. By choosing professional support, you invest in safety, stability, and the efficient launch of pharmaceutical manufacturing.

 Price

Legal and accounting support for the production of medicinal products — terms and cost of services

Project support is provided on the basis of a legal and accounting service agreement for business operations.

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LAW COMPANY EUROVECTOR