Quality Statement

At Salamandra, we know a quality system cannot be generic; it must reflect a company’s mission and be tailored to its products and processes. Salamandra’s goal is to help clients optimize pharmaceutical development, thus shortening the path to regulatory approval by

providing strategic input to the development process;
producing the best possible technical and regulatory submissions for review by regulatory bodies; and
offering detailed assessments of compliance status.

Salamandra’s management is dedicated to meeting these goals and committed to the appropriate application of regulatory standards and industry best practices to our own quality system.

Our Work Products

Salamandra provides strategic, technical, and regulatory assistance to clients engaged in drug, biologic and device development.

A key product is the original writing of the scientific and regulatory documents for submission to regulatory agencies.

Ancillary services include the production, submission and follow-up of applications, support in data analysis and interpretation, clinical study report writing, clinical trial safety monitoring, and postmarketing surveillance and adverse event reporting.

Also offered are client representation before pharmaceutical regulatory agencies, and for non-U.S. firms, U.S. Agency before the Food and Drug Administration.

The Key Elements of Our Quality Policy

Setting a gold standard

We compete on quality, and aim to set a gold standard with our work products. This means:

Doing it right the first time, as it saves time and money in the end.
Paying attention to detail.
Being timely in response and delivery.

Client-responsiveness

We serve clients in a regulated environment. That in itself imposes a quality structure. We live under the same standards as do our clients.

No project is the same. All of our work is uniquely tailored to each project’s circumstances and the client’s needs.

We maintain appropriate flexibility in our work procedures to meet diverse and changing client approaches to work.

We closely involve clients in the development of our work products.

We proactively anticipate clients’ future needs, and develop solutions before they are “needed yesterday”.

What might non-U.S. clients need? Working globally requires understanding international differences, not just in regulatory structures, but also in the practice of medicine, approaches to business, and cultural values and norms. Our staff members not only have significant international project experience, but either come from, or have lived in many areas of the world.

Strict confidentiality

Our work renders us privy to critical confidential and proprietary information, which must be rigorously guarded. This requires a continual improvement of internal systems, both technical and human, to prevent unauthorized disclosures. This is built directly into our quality system through self assessments and optimizations.

Staff development

Continual staff training and graduate education is fostered.

Staff are exposed to all aspects of our work, to promote ownership and responsibility for our work products. Through this cross training, our clients effectively gain access to the experience and talent of all staff members.

We cultivate the idea that quality at all levels has a direct impact on our ability to meet client expectations. Management not only promotes, but takes an active role in our quality system.

Every staff member is empowered to “stop production” and raise any concerns about the quality of a work product with top management.

The result is skill and dedication, and very low staff turnover.

Internal systems development

We undertake continual improvements of our internal operating systems and IT, including internal software development for specialized tasks such as eCTD submissions and project tracking.

An internal SOP development process is synergistic with our work developing SOPs for clients.

We encourage staff to admit mistakes, require that all errors be traced to their source, and prove that our corrections are effective. We implement prevention mechanisms at key points to bring about error-free products.

Ethical standards

We maintain the highest ethical standards in our work. We will not accept work assignments that conflict with our own ethical standards, even from existing clients.

QA/QC

We ensure the quality of our products through continual internal development covering key aspects of our work, proper project planning, objectivity, and adherence to scientific and regulatory principles. All of our final work products are required to pass through appropriate quality controls as defined by relevant SOPs, which are reviewed and improved upon regularly. Where necessary and appropriate, Salamandra will utilize the client’s SOPs.

Representations

Salamandra represents and warrants that neither the company nor its employees are nor have been, nor will it knowingly use in any capacity subcontractors who are, under investigation by the FDA for debarment or disqualification action or have been debarred or disqualified under the Food, Drug and Cosmetic Act or the Generic Drug Enforcement Act of 1992 or excluded from a Federal health care program.

Salamandra does not manufacture or market physical products, nor do we directly conduct laboratory or clinical studies. Therefore, common certifications such as I.S.O. quality registrations, or environmental, health and safety certifications are not pertinent to Salamandra, but we strive to incorporate appropriate concepts from such guidances as best business practices.

For pharmacokinetic and related modeling we use a licensed version of WinNonlin.

We have been building a reputation for quality and expanding our range of services since the company’s founding in 1996. Our client base and project portfolio have steadily increased since then, as has our international reach. All of our work is return business and by referral, an objective testimonial.