Services

Proposing and Implementing Development Plans

Hezareh can help bring your drug to market. Our experts can assist with:
- Identify a laboratory capable of formulation development
- Reformulation - Evaluate early formulations, including preliminary stability data
- Initiate stability protocols, monitor results, and prepare reports
- Preclinical and clinical development
- Bioequivalence studies

Pharmacoeconomy

We can identify strengths and weaknesses, and apply best practice to marketing processes, and allowing our clients to move forward and plan in confidence in following area:

- Technology Transfer
- Qualification & Validation
- Develop initial specifications as a basis for GMP manufacturing and scale up
- Providing EMA certificate and targeted countries certificate in international marketing
- Providing business plan & marketing plan
- Providing long-term strategic planning and short-term operational planning

Defining Regulatory Strategies

It is important to understand and define the clear regulatory strategies by considering the target markets/ regions, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets / regions. We provide technical support in the below mentioned areas:

- Dossier preparation & submission supported in CTD [Common Technical Document] format - Preparation of DMF [Drug Master File] and CEP [Certificate of Suitability] - Preparation of SMF [Site Master File] as per PIC/s & Local FDA requirement. - IRC [Iran Registration Code] submission

SOPs [Standard Operating Procedure] Preparation & Evaluation

Hezareh can provide you with SOPs templates to meet all regulatory requirements and guidelines (cGMP, GCP, GLP, DEA, OSHA, and ICH) and create customized SOPs to meet your company’s specific needs. In addition, we can provide the following services:

- Review & revise existing SOPs
- Author new SOPs
- Provide QA approval of SOPs
- Provide an annual review of your SOPs

Physicochemical Analysis

- Metal elements and heavy metal analysis
- APIs and finished products analysis

Portfolio Optimization

We can develop a structured and rational approach to successfully balance all the elements of our clients’ portfolios. To achieve this, we have given clients the tools and confidence to make objective decisions on product prioritization and revenue maximization with the points of increasing market share and promotion of efficiency.

Cost Effectiveness Analysis

We can aid our clients to decide about which medical care should be offered in those area:

- Cost Effectiveness
- Cost Benefit
- Cost of Preference

Project Management

We provide the client a brief idea about the cost effective concept engineering services and the feasibility of the proposal in view of the market, production volumes, provisions for expansion, design options etc. as mentioned below:

- Concept Engineering Services
- Qualification & Validation
- Standard Operation Services
- Quality Management System

Training Programs

Hezareh has an ability of development and delivery of customized training programs designed for personnel and managers with the necessary tools to ensure understanding of complex subject matter. We can help your company stay compliant and current with FDA, MHRA, DEA, OSHA, ICH, and ISO regulations and guidelines, marketing plans, business plans and CTD writing.