Our experienced PharmEng consultants strive to exceed your project goals and objectives. We understand the importance of developing the most effective and strategic approach that will meet your project schedules and budgets. Our Subject Matter Experts (SME's) thrive on implementing the latest industry strategies to meet your organizational and regulatory needs, as well as the current global regulatory requirements.
PharmEng has an extensive background in completing Validation Projects; these include cleaning, facility and utility, equipment, process, and computer validations.
Our clients understand the importance of investing in an efficient and effective quality system; The effort in maintaining a balanced quality system not only ensures that the best products and services are offered, it directly benefits our clients’ business through cost savings and improved sales.
PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natural Health Products, Personal Care, Disinfectants, and Active Pharmaceutical Ingredients (API) to achieve the most cost-effective way to undertake their regulatory activities worldwide. This includes regulatory intelligence and strategy, worldwide product registration, preparation of regulatory documents, in country representation, establishment registration, and post-approval submissions.
PharmEng engineers are experienced in building scalable and robust pharmaceutical production facilities and processes while employing state of the art techniques to meet and exceed operational and regulatory requirements.
Training is an integral part of GMPs. The operations involved in the manufacture of regulated products are highly technical in nature. Inadequate training of personnel can result in products failing to meet the required standards. During inspections, regulatory agencies often find problems related to training programs.