Lovell Law Group consults with its clients to help them implement compliant and cost-effective solutions for contract management.
For pharmaceutical and biotech companies, the law sometimes can seem like a moving target. Whether it’s the enactment of a new statute, promulgation or reinterpretation of an agency regulation or guidance, or adoption of new industry codes, companies recognize the critical importance of getting contracts right. Companies also increasingly recognize the critical—but sometimes overlooked—importance of making sure that contracting practices adapt to the ever-changing landscape—and unprecedented level of scrutiny—in the legal, compliance and regulatory arenas, including:
- the Federal Anti-Kickback Statute and its Safe Harbors;
- aggregate spend reporting under the Physician Payment Sunshine Act and state transparency laws;
- FDA Debarment and Exclusion requirements; and
- the Foreign Corrupt Practices Act.
It is equally important that contracting be accomplished efficiently, in a manner that minimizes business disruption. As a result, companies are adding resources to ensure that contracts flow correctly within the organization.
To comply with these evolving and complex requirements, companies must train vendors to collect data, implement new policies and procedures and purchase (or build in-house) aggregate spend or transparency solutions.
In short, companies have to be able to efficiently and cost-effectively track, collect and report data.
- Contract Flow: Lovell Law Group works closely with its clients to determine the most efficient corporate chain for contract flow and data capture. Organized contract flow within a company not only ensures compliance with all internal policies and procedures, but it also ensures that the company and its vendors are tracking, collecting and reporting data where necessary. Contracts flow differently through each organization depending on its size and needs.
- Contract Management Software: Lovell Law Group has assisted its clients with the purchase of out-of-box contract management software. We can also manage the in-house build of such software. We partner with you to create a tailored plan that accomplishes your goals in a way that works for you and your budget.