Pacific-Link Regulatory Consulting, Inc.

We bring your products to market by quickly identifying clinical and economic needs, reimbursement strategies, and the best route to market. Our goal is to help clients maximize the value and life cycle of their product amid a constantly-evolving regulatory environment. Our core service is regulatory, and as experts in the field, we’re constantly called on to explain how international drug registration functions and why it has to be so complicated. While we specialize in regulatory, we also provide services in all related areas, ensuring that our clients obtain market access with an appropriate price and reimbursement level. We believe in the individual potential of all our employees and it is through their knowledge, experience, and eagerness to take on challenges that we continue to offer personalized solutions to unique problems for all our clients. From strategy to implementation, our global regulatory experts will achieve successful commercialization and compliance for your product. We enjoy taking on ambitious projects and understanding your product’s challenges is the heart of what we do. Our team is part of the world's most extensive network of professionals, composed of leading industry and academic experts in clinical medicine, biology, and pharmaceutical sciences.

Our services are defined by a direct personal contact, offering a senior level of expertise, supported by a strong network of scientists and senior partners. Our mission is to excel in delivering the best technology, clinical, regulatory, and medical expertise, for the fullest benefit of our customer. Supported by a network of senior partners, we are committed to establishing a trusted relationship with each of our clients. We focus on value-added custom services, conforming with the best practices (GMP, GDP) and ISO norms (9001, 13485). We strive to understand and embrace your vision and business goals, to deliver services that are tailored to our customer's expectations.

We are now US licensee of this software. Our company’s mission is to provide outstanding technical and regulatory compliance assistance to enable our clients to meet their product objectives. In fulfilling this mission, we act as a bridge from our clients problems to great solutions, developed in partnership. The demands of the modern healthcare product industry are such that a one-size-fits-all approach is no longer relevant and this is giving way to a more tailored bespoke approach where boutique style and quality approaches are required to produce the right solutions with the appropriate quality. It’s important that quality is built in to assure performance and confidence and processes need to be streamlined to produce a portfolio of solutions to meet the variable needs of the client. In fulfilling this role, we provide services in a number of broad categories including, but not limited to:. We have expertise in solid dosage forms, parenteral pharmaceuticals, a wide range of biological products, vaccines, recombinant products, monoclonal antibodies, cell therapies, tissue engineered products and device-combo products. With the continued expansion of clinical products entering trials, the need for both clinical supplier audits and regulatory agency audits is set to increase significantly.

We provide consulting services to life sciences companies globally. We are unique in having the processes and resources in place to provide rapid turnarounds with global projects. Our services are designed to help with Market Access, Business Development & Licensing, Business Analysis, Strategic Planning, Strategic Marketing and Pricing & Reimbursement. Our offerings are designed to maximize returns from your R&D, business development, licensing and marketing efforts. The information and analysis that we deliver along with our decision tools facilitate structured thinking and decision making. We run workshops and participate in on-site meetings as needed to provide support to clients during projects. With many projects, we can deliver outputs in under 4 weeks from commissioning. We have the skills and resources to conduct market, product and service evaluations globally – USA, EU, Japan, China – including emerging markets.

We provide alignment between the numerous strategic planning and operational activities required prior to, during, and following product launch. We are committed to serving our stakeholders with services and solutions that improve healthcare technology, processes, and ultimately patient outcomes. It offers a wide range of services to the medical device, pharmaceutical and biologics industries. In sum, this leads to the founding of several new affiliate companies offering services ranging from clinical trials to the development of electronic quality management systems. It has also acquired or established several related consulting firms in an effort to provide a global footprint and to meet the growing needs of its clients. Our objective is to provide in-country representation and regulatory agency submissions. Extensive internal expertise is supplementing by a solid network of diverse subject matter experts. Which enables our team to provide a full suite of development and commercialization services to clients.

Our mission is to keep abreast of the ever-changing guidelines worldwide. We are a diverse group with ties to Africa, South America, and Asia, speaking English, French, Spanish, Amharic and Tigrinya. Because we are well known in the Cosmetic / OTC Drug and Chemical industries in the United States, the United Kingdom and Europe, we have ongoing speaking requests from a variety of associations and workshops. Our mission is to stay ahead of regulatory guidelines worldwide.We customize both our domestic and international services to the client’s needs, even if our client is unaware of the exact services they may require. However, as the regulatory and cosmetics worlds developed, many manufacturers began outsourcing for their regulatory information so they could keep their costs competitive. Many buyers wanted turnkey product at the lowest price possible and manufacturers could no longer afford to have specialized regulatory personnel. It was apparent that with the expansion of brand owners’ use of contract manufacturers, there often is a gap in knowledge and a service need for regulatory requirements. With 13 years in corporate manufacturing &formulary and 3 years behind the scenes of Herbalife licensing, Janet Winter was encouraged by industry leaders to fill a much-needed niche.