Regulatory Consulting For Companies In The Pharmaceutical Sector

ANVISA requires detailed technical dossiers with data on efficacy, safety, and quality. Common errors include:

• Incomplete studies: Lack of clinical trials or stability analyses;
• Labeling issues: Outdated information or information not aligned with RDC 47/2009;
• Failures in the good practice manual: Unvalidated manufacturing procedures.

Solution: Specialized consultancies conduct preliminary audits to identify gaps, reducing the risk of rejection by 70%.

I WANT A SPECIALIZED CONSULTANCY

1. Intelligent grouping of records
   Companies that submit batches of similar products (e.g., generics from the same line) in a single process accelerate analysis by 30%, taking advantage of document synergies.
2. Proactive regulatory monitoring
   With 15 annual updates to ANVISA standards, alert systems prevent delays. E.g.: New rules for biological medicines (RDC 876/2024) require immediate adjustments to protocols.
3. Centralized management in the Solicita system
   ANVISA's official platform for petitions requires valid digital certificates and accurate completion. Consultancies avoid technical failures that stall 25% of processes.

I NEED TO REGISTER MY MEDICINE WITH A STRATEGY

Medicines containing substances subject to special control require:

• Specific authorizations: AFE (Company Operating Authorization) and AE (Special Authorization) for production;
• Enhanced traceability: Audited logistics systems and monthly sales reports;
• Controlled prescription: Use of blue (type B) or yellow (type A) prescription forms.

Relevant fact: 90% of bans in this category occur due to failures in transport or storage documentation.

Changes to already approved products (e.g., change of raw material supplier) require prior approval. Critical steps:

• Correct classification of the change: “Minor” changes (e.g., packaging) have a simplified procedure;
• Complementary studies: Validation of equivalence for new ingredients;
• Agile communication: Notification via Solicita within 30 days after the modification

I NEED TO CHANGE MY REGISTRATION

Transforming regulatory complexity into a competitive advantage requires more than technical knowledge; it demands strategic experience. Stone Okamont offers tailor-made solutions for pharmaceutical companies:

• Failure prevention: We conduct audits of documents and facilities, eliminating non-conformities before submission to ANVISA;
• Acceleration of deadlines: We manage the entire registration cycle—from the technical dossier to the issuance of GMP certificates—reducing time by 60%;
• Ongoing support: We monitor renewal deadlines and legal updates, such as new rules for cannabis-based medicines;
• Preparation for inspections: We simulate ANVISA audits, training teams in responding to technical questions.

Stone Okamont combines regulatory depth with practical solutions, transforming requirements into opportunities for growth. Request an assessment and find out how to simplify your path to registration.