1. Drug Manufacturing License Services

• Description: Assistance in obtaining a drug manufacturing license for businesses engaged in the production of pharmaceutical products, including Allopathic, Ayurvedic, Homeopathic, and Veterinary drugs. This process involves meeting infrastructure, staffing, and equipment standards required by the licensing authority.
• Benefits: Enables businesses to legally manufacture drugs under regulatory standards, ensuring safety and quality in the production process.

Key Services: – Evaluation of eligibility and setup requirements for drug manufacturing – Preparation and filing of applications for licenses, including Form 24 and Form 25, based on drug type – Assistance with plant inspection, documentation, and approval from the state Drug Control Department

2. Drug Sales License Services (Wholesale and Retail)

• Description: Support with obtaining a drug sales license for businesses engaged in the wholesale or retail sale of drugs, which includes both prescription and over-the-counter medications. Wholesale licenses are issued in Form 20B/21B, while retail licenses are issued in Form 20/21.
• Benefits: Ensures compliance with regulatory requirements for drug sale, allowing businesses to legally sell pharmaceuticals while adhering to safety and handling guidelines.

Key Services: – Assistance in choosing the correct license type (wholesale or retail) based on business needs – Preparation of application forms, including required documents like pharmacist qualifications and premise details – Coordination with local Drug Control Department for site inspection and license issuance

3. Cosmetic Manufacturing License

• Description: Assistance with obtaining a cosmetic manufacturing license for businesses that produce or package cosmetics. This includes compliance with good manufacturing practices (GMP) and maintaining appropriate facilities to ensure product safety and hygiene.
• Benefits: Provides businesses with legal permission to manufacture cosmetics, establishing credibility and enabling market entry in compliance with quality standards.

Key Services: – Preparation of application documents and site readiness for inspection – Filing applications with the state FDA office for licenses under Form 32 (for cosmetics manufacturing) and Form 37 (for loan licensing) – Assistance with compliance inspections, record-keeping, and ongoing adherence to GMP

4. Loan License for Manufacturing

• Description: Assistance in obtaining a loan license, which allows a manufacturer to use another licensed manufacturer’s premises to produce drugs or cosmetics under their own brand. This is particularly useful for businesses without dedicated manufacturing facilities.
• Benefits: Provides flexibility to small manufacturers, reducing infrastructure costs while enabling production under strict regulatory guidelines.

Key Services: – Preparation and filing of applications for loan licenses under Form 24A for drugs and Form 37 for cosmetics – Assistance with agreements, document submission, and compliance checks – Coordination with drug authorities to ensure legal and regulatory compliance

5. Import License for Drugs and Cosmetics

• Description: Support for obtaining an import license for drugs, cosmetics, and related products. This includes compliance with the Central Drugs Standard Control Organization (CDSCO) requirements, ensuring that imported products meet safety and quality standards.
• Benefits: Enables businesses to legally import drugs and cosmetics into India, ensuring compliance with regulatory standards and expanding product offerings.

Key Services: – Preparation of the import application under Forms 10, 10A, or 41, depending on the product type – Coordination with CDSCO for product registration, sample testing, and import approval – Assistance with ongoing compliance for imported goods, including customs clearance support

6. Good Manufacturing Practice (GMP) Certification

• Description: Assistance in obtaining GMP certification, a quality standard required for drug and cosmetic manufacturers in India. GMP certification ensures that products are consistently produced and controlled according to quality standards.
• Benefits: Enhances product quality, improves market credibility, and facilitates access to markets requiring GMP-compliant products.

Key Services: – Guidance on setting up GMP-compliant facilities, equipment, and processes – Assistance with documentation and filing for GMP certification with the regulatory authorities – Support with regulatory audits and follow-up for GMP compliance approval

7. License Renewal and Modification Services

• Description: Assistance with renewing or modifying existing drug and cosmetic licenses, ensuring continued compliance. Renewal is essential to maintain a license’s validity, while modification services help update licenses in case of business changes, such as new products, changes in location, or modifications in production capacity.
• Benefits: Helps businesses avoid penalties or disruption due to expired licenses and ensures licenses accurately reflect the current business status.

Key Services: – Preparation and filing of renewal applications before license expiry – Assistance with modification applications for updating details on existing licenses – Liaison with regulatory authorities to ensure smooth processing of renewals or modifications

8. Regulatory Compliance and Ongoing Support

• Description: Ongoing support to ensure businesses remain compliant with drug and cosmetic regulatory requirements, including record-keeping, batch documentation, sample testing, and adherence to labeling standards.
• Benefits: Maintains the business’s compliance with the law, ensuring quality control, safety, and regulatory adherence, reducing risks of penalties.

Key Services: – Advisory on labeling, packaging, and quality control standards for drugs and cosmetics – Support with maintaining records, test reports, and regulatory documentation – Regular compliance check-ins to stay updated on any regulatory changes

9. Assistance with Regulatory Inspections and Audits

• Description: Guidance and preparation for regulatory inspections by authorities such as the state drug controller or CDSCO. This includes audit preparedness, documentation, and assistance with responding to inspection reports.
• Benefits: Helps businesses pass inspections smoothly, avoid non-compliance issues, and build a strong reputation with regulatory authorities.

Key Services: – Preparation for site inspection, including required documentation and facility checks – Guidance on corrective actions for any regulatory observations or deficiencies – Ongoing support to ensure that the premises and operations meet regulatory expectations

10. Consultation and Advisory for New Product Launches

• Description: Advisory services for businesses planning to launch new drugs or cosmetics in India, covering compliance requirements, licensing needs, and regulatory guidelines for new products.
• Benefits: Provides businesses with a clear understanding of the regulatory landscape, helping them bring new products to market while ensuring full compliance.

Key Services: – Regulatory consultation for new product licensing requirements – Guidance on product testing, labeling, and quality standards – Assistance with the application process for product-specific licenses