Conceptual design and detailed engineering

We will design your facility in accordance with current Good Manufacturing Practice recommendations, as well as all applicable regulatory requirements. We will also facilitate obtaining necessary approvals from regulatory authorities. Only after the essential approvals on the conceptual design have been obtained, we will perform detailed engineering on the project to ensure its seamless operation.

The detailed engineering will encompass engineering drawings and technical specifications including architectural and structural engineering, Selection, Supply, Installation & Commissioning of Production and Packaging machinery, HVAC system, air filtration systems, water purification system, service utilities, electricals & electronics, building automation systems, fire & safety and other systems.

Cleanrooms

We will define a cleanroom that is appropriate for your manufacturing operations, considering your manufacturing processes, process equipment, product mix, manufacturing capacity, ventilation requirements, and other details.

Our cleanrooms are designed and built in modules to minimize the amount of time spent on the site. Furthermore, our turnkey solutions come with adequate training, requiring minimal involvement on your part.

Manufacturing processes

We will design raw material handling, intermediate processing, and finished product equipment in accordance with the production process requirements. Furthermore, we will outline the specifications for the facilities, utilities, and any other support systems that are required.

Lean manufacturing techniques will be designed to improve productivity and minimize costs. We will help you introduce innovative technologies to simplify manufacturing operations.

Compliance (regulations and quality)

Pharmaceutical, cosmetic, and medical device manufacturing is highly regulated, requiring extensive knowledge of regulations and standards. We will assist you in gaining accreditation from both local and international regulatory agencies. We will commission, qualify and validate your facility in line with regulatory requirements. .

We will help you comply with risk-based regulations, quality-by-design, quality systems, process analytical technology (PAT), and other initiatives.

Project management

Obtaining a profitable return on investment is essential to the foundation of any organization. We will ensure that your project is planned so that it can be completed on time and within budget. Our plans will include scheduling, resource allocation, budgeting, supplier selection, procurement, installation, and commissioning. The project plan will be structured by using defined decision points and milestones.

Our efficient operational and executive governance procedures will give an effective support framework to keep track of the important metrics critical to your project's success.

We coordinate activities such as: API selection and procurement, reference product identification and procurement, formulation and process development, clinical development, technology transfer, registration and commercialisation.

We will perform investment feasibility analysis, gap analysis, and expert reviews for your projects.

Training

We are confident that we can assist your organization by offering the knowledge and resources needed to improve compliance, performance, and effectiveness in crucial areas. Our expert advisors have worked with both the larger global pharmaceutical giants as well as growing and start-up businesses. We will assist you in developing a robust QMS to fulfill cGMP requirements, thereby strengthening your in-house competence.