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Regulatory Practice: Critical Insights & Rich Talent Pool.
Our Regulatory Practice serves clients across the Life Sciences Industry, including pharmaceuticals and biotechnology, cell and gene therapies, veterinary medicine, medical devices, in vitro-diagnostics and digital health. We provide insightful, timely solutions to meet the scope of regulatory challenges.
ALG advises leading international companies on the full range of strategic issues covering the life cycle of a product –from concept and development to market.
Extensive Expertise
Advising on clinical trials, marketing authorizations, CE Marking.
Advice on legal implications of regulatory actions (market access, recalls etc.) and relations with distributors and sellers.
Advising on treatment and validity of various discounts-rebates.
Advice on Regulatory rights for products under development in accordance with legal framework (such as market and orphan exclusivities, SPC and pediatric rewards).
Competent understanding of the new EU legislation affecting medical device and IVD companies due to the MDR (and IVDR) revolution.
Representation before national and European courts, as well as before competent authorities (European Commission, EMA).
Compliance Practice: Wealth of Experience & Solid Bench Depth
Life Sciences companies face an unprecedented level of scrutiny in the legal, regulatory, and compliance arenas. ALG is highly regarded for our broad experience and substantial bench depth, ensuring knowledgeable, on-going support.
Our lawyers are passionate about developing creative, cost effective compliance solutions for Life Sciences companies.
ALG provides a wide range of compliance advisory services to pharmaceutical, medical device, and biotech companies at every stage of development.
All-Inclusive Support
Assessment of internal HCP, HCO and vendor request forms’ compliance with local legislation, codes of conduct and company’s SOPs and policies. Interaction with requestors in case of queries or designated mailboxes or databases for contracts
Development, review and update of Policies and Standard Operating Procedures (SOPs) documentation.
Monitoring Support for compliance programs, including common monitoring areas (promotional material, engagement of HCP, HCOs, meetings and events etc.).
Training to Pharma Companies on Compliance regulatory framework and guidelines for interactions with HCPs/HCOs.
Support as external counsel on whistleblowing and investigation procedures on alleged misconduct cases.
Advise on anti-kickback considerations and compliance with industry standards.
Prepare audits, gap analyses, and risk assessments of companies’ compliance policies to identify potential gaps and necessary additional policies and procedures.
Perform due diligence for vendors, sellers and distributors
