wbPD

Industries

Pharmaceutical

The Pharmaceutical industry is dominated and challenged by its constant evolutionary environment and latest breakthroughs in drug related technologies. It is often strongly characterized by unpredictable changes in regulatory action and compliance policies. Life Sciences and Technology Consulting brings you feasible and fully integrated solutions provided by its well-equipped team with knowledge and experience of FDA authorities. Our expertise span across product innovation, space design, legalities, paperwork, cost management and various other aspects crucial to your success as an industry leader. We provide a diverse range of services, such as meeting industry compliance and regulatory requirements set by the FDA, training and technical assistance with professional development, and other related services. We can also help prevent and resolve all your existing compliance and regulatory issues, get you FDA approvals for new product developments, and assist with inspection audits and regulatory submissions.

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Biopharmaceutical

The bio pharmaceutical industry is a maturing industry with immense potential of becoming the core of the pharmaceutical industry. However, for that, it is important to drive significant transformation in the laboratory and in strategy, technology, and operations of this industry. Owing to the increasing patient population and subsequently rising needs for healthcare, the industry must keep up with increasing generic competition and greater regulatory expectations in order to be successful. With Life Sciences and Technology Consulting and our expert team, you can get assistance with product innovation, space design, legalities, paperwork, cost management and various other aspects to help you take your practices and services up a notch.

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Over the Counter

Every year, there is a huge number of over-the-counter (OTC) drugs being marketed in the United States. Therefore, FDA imposes strict regulation criteria on those conducting OTC drug businesses. Companies involved in OTC drug manufacturing, preparation, and processing are strictly required to follow certain protocols and compliance requirements set by FDA. Life Sciences and Technology Consulting can help these companies meet the set requirements and achieve supreme standards of safety and quality. We also assist with acquiring licenses to manufacture and sell OTC drug products, as well as with any existing products and lodged customer complaints or warning letters issued by FDA, using our extensive knowledge, expertise, and laboratory testing facilities.

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Medical Devices

Life sciences companies selling medical devices are heavily regulated and must adhere to certain practices and follow a strict code of conduct to avoid permanent damages and threat to their existence. As according to STAT, medical devices have been reported to cause more than 80,000 deaths since 2008. In order to protect patients and diminish deaths caused by medical devices, regulatory bodies such as FDA and ISO have introduced strict compliance guidelines for companies manufacturing and selling these devices. By focusing on a quality-driven mindset and addressing problems from conception till completion, companies can not only make sure their product is deemed fit for use by the authorities, but can also avoid disastrous possible outcomes for their company’s name and reputation. Our professional and experienced team can assist you with issues such as compliance, warning letters, staff training, risk management, CAPA cited complaints (documentation, data analysis break down and investigations), customer complaints and data integrity.

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Clinical Research

Building a compliance focused culture is imperative to overall success of health care facilities. Being well-acquainted with industry advancements and new regulatory developments is crucial to ensuring safer more quality practices, exemplary patient care, long term business profitability and safety against financial penalties and retribution. Providing consistent and quality education and regulatory compliance training to health care professionals and staff is vital as human error can prove to be daunting and poses one of the biggest threats to any health care organization.

In view of the difficulties and compliance failures often encountered by every health care organization in business no matter its size, an effective compliance program needs to be in existence to safeguard its practice, income and patients. Many health care facilities and centers are still lacking an aggressive and financially advantageous approach that will help them build better and safer businesses.

Our team of professionals can intervene and help build up and boost compliance for your health care practice before authorities run their mandatory regulatory checks and hefty fines are imposed due to ignorance, sheer negligence or failure to comply. Our main contribution is about FDA related services such as remediation, 483's, warning letter, regulatory submission, etc.

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