The health market in the world is characterized by frequent changes, competitiveness, complexity requiring dealing with business challenges, and is subjected to broad regulation. Understanding the business environment, as well as identifying problems of which the organization needs to deal with at certain periods of time, and presenting possible solutions, will lead to making informed decisions for your organization.
Barrco Regulatory Solutions assists your organization with making the right decisions in order to act more effectively in obtaining the goals of the organization and actualizing its full potential.
– Cases requiring strategic consulting in the field of health products.
– Entering a new market.
– Activities in a field that is absolutely unfamiliar.
– Preparing a business plan.
– Lack of success in achieving an important assignment.
– Dealing with complex regulatory requirements.
– A crossroad in which there is a need to choose the correct path for the organization.
– Response to legal challenges.
– Preparing a risk management plan.
– Effective conduct when dealing with customers and suppliers.
– Strategic consulting.
Barrco Regulatory Solutions employs a team of the most experienced experts that acts successfully for many years in a challenging environment of the Israeli health market. The team of employees is available for you at any time to provide regulatory, business and marketing consultation in the health field, advice given based only on facts!
The professional broad knowledge that we have gained throughout the years, will enable you to receive full value for every consultation, including on the following issues:
– Successfully handling challenges of the health market before opening an agency in foreign country.
– Review of the health market in Israel and implications on considerations for marketing medical products.
– Audits by the Health authorities.
– Inspection and management of suppliers and subcontractors of the pharmaceutical field.
– Efficient management of the inclusion process of medicinal technologies into the health basket.
– Establishing a registration system for big companies and small businesses in the health products’ field.
– Handling rejection of a submission that has been submitted for the approval by the Health authorities.
– Creating a risk management plan and providing proper response to events that may jeopardize the business activities.
– Renew a license of a healthcare related products.
– A schedule for regulatory activities required before launching the product after receiving market approval.
– Rights and duties of registration holders from the point of view of the Health Authorities, hospitals and pharmacies.
– Preparation and/or upgrading of agreements in the health field: quality agreement and safety agreement (pharmacovigilance).
– Cost/benefit analysis regarding compliance with regulatory and marketing requirements of the health field.
– Business opportunities for importers of medicines and medical devices.
– Legal aspects accompanying local manufacturing, importing and marketing of health field products.
– Regulatory opinion for legal discussions.
Barrco Regulatory Solutions is your business partner for making educated decisions during the various stages of the life cycle of products of the health field! We will provide you with the value you expect to receive for your investment.