Legal Practice

Pharmaceuticals, Healthcare & Life Sciences

<p>Legal compliance under Drugs Act 1940, DGDA manufacturing licensing, clinical trial contracts, medical negligence defense, and healthcare M&A.</p>

Scope of Legal Practice & Representation

Pharmaceutical manufacturing and clinical healthcare operate under extensive public health regulations. ZCA LEGAL provides strategic counsel to pharmaceutical corporations, medical device importers, diagnostic hospital chains, and healthcare practitioners under the Drugs Act 1940 and the National Drug Policy 2016.

Healthcare & Life Sciences Capabilities

  • DGDA Licensing & Recipe Approvals: Securing pharmaceutical manufacturing licenses, recipe certifications, and Maximum Retail Price (MRP) approvals from the Directorate General of Drug Administration.
  • Clinical Trial Contracts: Drafting clinical trial protocol agreements complying with Bangladesh Medical Research Council (BMRC) ethical guidelines.
  • Active Pharmaceutical Ingredient (API) Supply: Drafting cross-border API procurement contracts, tech transfer licenses, and contract manufacturing agreements.
  • Medical Negligence Defense: Defending hospitals and medical specialists before BMDC disciplinary tribunals, civil courts, and criminal courts against unsubstantiated negligence claims.
  • Healthcare Mergers & Acquisitions: Conducting due diligence and structuring acquisitions of private hospital chains and diagnostic centers.

Protecting Health Innovation

We ensure life sciences companies operate with full statutory compliance while defending the medical profession with courtroom rigor.

Step-by-Step Legal Procedure

1
Preliminary Consultation & Fact Assessment Evaluating client business model, relevant laws, and drafting roadmap.
2
Document Vetting & Statutory Drafting Preparing customized agreements, petitions, affidavits, and board resolutions.
3
Regulatory Filing & Hearings Submitting to RJSC / High Court / NBR / BIDA and conducting judicial hearings.
4
Certified Execution & Compliance Delivering certified licenses, court orders, and ongoing retainer support.

Required Documentation Checklist

National ID / Passport copy of directors or applicants
Registered commercial office tenancy agreement & utility bill
Trade License, e-TIN, and relevant sector permits
Draft agreements, bank return memos, or existing correspondence