Legal Support
Providing Legal Oversight to Support Business Growth
For companies in the life sciences industry, including pharma, bio-tech, med-tech, R&D sectors, navigating the legal landscape is complex, challenging and ever changing as the science develops.
We provide expert legal support for businesses operating in the life science space across the globe, including UK/EU, Asia PAC, US, & LATAM.
Providing legal support across the life sciences sector for 20+ years
At LS Law, our global network of consultants have a deep understanding of the industry’s legal backdrop which allows them to identify challenges, & mitigate risks. We ensure compliance with industry regulations are embedded into our clients business strategy, which enables them to deliver business goals whilst knowing the legal landscape has been taken into account and the business is protected.
From assessing the regulatory landscape of a particular jurisdiction, clinical trial support to engagements with healthcare professionals, contracts and supply chain, protection & licensing of intellectual property, to the development of external facing materials, non-promotional activities and patient support initiatives, pricing & reimbursement we provide a comprehensive legal and compliance support service which serves your particular needs and adapts as you grow.
Animal Health
Medical Devices
Consumer Health and Well-Being
Medicinal Products
Research & Development
Regulatory Affairs
Data Privacy
Our Legal Expertise includes:
Intellectual Property Protection & Collaborations
Our legal team specialise in Intellectual property protection & collaborations for the life sciences sector. Whether in-licensing, out-licensing, partnerships, collaborations, M&A, we can manage this ensuring complex arrangements regarding Intellectual Property ownership, rights and restrictions are clear. We safeguard innovations in biotechnology, pharmaceuticals, and medical devices, ensuring strategic partnerships and licensing arrangements are crafted to protect and to maximise the value of intellectual property.
Pharmaceutical & Medical Device Regulations
Our expert consultants offer legal support in pharmaceutical & medical device regulations, taking into account the complexities of the changing legislation, ensuring regulatory requirements, approvals, and compliance strategies for businesses in the life sciences sector are covered.
Interactions with Healthcare Professionals (HCPs) & Transfers of Value
We offer expertise in navigating industry regulations which govern interactions with healthcare professionals and disclosing transfers of value, and ensuring transparency reporting complies with regulatory requirements. Our tailored strategies support businesses in fostering professional relationships with healthcare professionals while adhering to regulatory requirements. From drafting HCP contract templates, formulating approval processes, to handling the collation and reporting of transfers of value into public facing portals.
Clinical Trial Regulation
Our consultants are on top of the emerging global changes taking place in clinical trial regulations, to take into account the digital era, and the expansion of digital clinical trials, and the nuances which need to be factored into clinical trial design in addition to traditional clinical trial design. We support businesses through the intricate process of conducting clinical trials. Our expert group of consultants offer support navigating regulatory frameworks, ensuring compliance with laws and guidelines governing clinical research. Our tailored strategies support businesses in efficiently navigating the complexities of clinical trial regulation, facilitating the development and approval of innovative medical treatments and therapies.
Distribution, Supply Chain & Contract Management
At LS Law we aid clients with distribution, supply chain & contract management, offering guidance on optimising operations and ensuring compliance. We help to streamline distribution networks, optimise supply chains, and negotiate contracts to maximise efficiency and profitability for businesses, taking into account stock management planning to ensure continuity of supply, competition law issues, as well as the more practical aspects of ensuring quality is maintained for cold-chain and ambient products, duration of travel concerns, storage and security, labelling and import/export matters.
Consumer Health & Wellbeing Regulations
We provide expert guidance helping businesses navigate the complexities of regulations governing consumer health products, ensuring adherence to standards while promoting consumer safety and wellbeing. Consumer safety, and the guidelines surrounding how these products are marketed and positioned is a delicate balance, to ensure their correct categorisation as a medicinal product -v- a medicinal product and the requirements of MHRA and other jurisdictional regulations are adhered to.
Animal Health Regulations
The Regulations surrounding animal health products are services that require a high level of understanding to ensure products and services in this area are compliant. We have a team of lawyers who have a huge amount of experience in navigating the complexities of this area of the law. Pricing can be complicated, with rebates, discounts and other pricing arrangements associated with KPI’s is the norm, and a high understanding of competition law issues as well as the industry regulations on how they can be marketed is a niche specialisation, which we have here at LS Law.
R&D, Clinical Trials and CRO Contract Management Support
Our legal team offer specialised support with devising and negotiating agreements to manage the relationships between clinical trial sites, out-sourced clinical research organisation (CRO) and the drug manufacturer, as well as protocol development, liaising with the authorities to obtain authority to conduct the trial, as well as other issues which may arise through the duration of the trial, including supply chain matters. We will also ensure patient consents to participate, patient information sheets, and participation criteria, adverse event reporting and other fundamentals are clear, factoring in the sensitive nature of the data to be collected and patient safety is paramount.
We offer legal support to help businesses manage their clinical research projects, crafting consents, collection of data is compliant, and documentation easily understood, ensuring efficiency. With tailored solutions, we assist organisations in navigating the complexities of conducting a clinical trial, , optimising operations, and facilitating successful clinical research collaborations.
Data Protection and Data Privacy Officer Support
We supply bespoke solutions to ensure data privacy is protected, whether through the provision of a data privacy officer (DPO) service, or general support. From drafting data privacy policies, to providing data privacy assessments and training. We offer specialised support which facilitates compliance with data privacy regulations.
Our tailored solutions assist businesses in fulfilling their obligations under data protection laws, ensuring the privacy and security of personal data. With our support, businesses can navigate the complexities of data protection requirements effectively, mitigating risks and maintaining positive relationships with stakeholders.
Industry Code & Compliance
The industry codes are there to ensure patient and public safety is of the highest priority. Being principles based, they can be hard to navigate, and requires experience working within the industry to understand how they play out and ensure the company is the right side of the line with its materials and activities, with safeguards in place to facilitate compliance.
With our support, organisations can mitigate legal risks and maintain ethical standards, fostering credibility within the industry ensuring high standards are maintained. We will support the development of materials and conduct of events by factoring in the industry codes, whether that’s putting together a compliance road map, drafting Standard Operating Procedures (SOPs), the provision of training, or setting up a whistleblower hotline, or supporting internal investigations. We have it covered.